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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

    Protocol: GOG-0281

    Eligibility:

    Inclusion Criteria:

    • Patients with the following tumors are included in the study:
    • Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, Federation of Obstetricians and Gynecologists [FIGO], World Health Organization [WHO] or Silverberg)
    • Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)
    • At least 4 weeks must have elapsed since the patient underwent any major surgery (eg. MAJOR: laparotomy, laparoscopy, thoracotomy, VATS [video assisted thorascopic surgery]); there is no restriction on MINOR procedures: (eg. central venous catheter placement, ureteral stent placement or exchange, tumor core or fine-needle aspirate [FNA] biopsy)
    • Patients must have documented low-grade serous carcinoma; confirmation must occur by prospective pathology review prior to study entry; the prospective pathology review can be done on tissue from the recurrent carcinoma or from original diagnostic specimen
    • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be > 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI; all imaging studies must be performed within 28 days prior to registration
    • Prior therapy
    • Patients must have recurred or progressed following at least one platinum-based chemotherapy regimen
    • Patients may have received an unlimited number of prior therapy regimens
    • Patients may not have received all of the five choices in the "standard therapy" arm
    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
    • Any other prior therapy directed at the malignant tumor, including chemotherapy and radiation therapy, must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 28 days prior to registration
    • All patients must have an image-guided fine needle aspiration/core biopsy of fresh tissue (snap frozen) obtained after signing consent and prior to randomization submitted for translational research
    • Women of childbearing potential (i.e. patients whose reproductive organs remain in place and who have not passed menopause) and men must agree to use a highly effective method of contraception (e.g. hormonal, intrauterine device or; abstinence*) prior to study entry, during the study participation, and for six months after the last dose of the drug; women of child-bearing potential must have a negative pregnancy test within 14 days prior to randomization, cannot be breast-feeding, and must agree to use a highly effective form of contraception throughout the treatment period and for 6 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; * abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the patient
    • Patients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health information
    • Patients must have a GOG performance status of 0 or 1
    • Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome, bowel obstruction, or major resection of the stomach or bowel
    • All prior treatment-related toxicities must be CTCAE v4 grade < 1 (except alopecia) at the time of randomization
    • Patients must have a left ventricular ejection fraction >= lower limit of normal by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
    • Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
    • Bilirubin =< 1.5 times upper limit of normal
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times upper limit of normal
    • Albumin >= 2.5 g/dL
    • Prothrombin time (PT) and activated partial thromboplastin time (APTT) =< 1.5 times upper limit of normal
    • Neutrophil count >= 1.5 x 10^9/L
    • Platelet count >= 100 x 10^9/L
    • Hemoglobin >= 9.0 g/dL
    • If letrozole is selected as the control therapy, patients must be postmenopausal, either following bilateral oophorectomy or at least 5 years after spontaneous menopause; patients within 5 years of spontaneous menopause or who have had a hysterectomy without bilateral oophorectomy must have postmenopausal luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels; patients on hormone replacement therapy (HRT) must agree to withdrawal of hormone therapy before letrozole is started

    Exclusion Criteria:

    • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
    • Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib or standard of care agent
    • If patients have had a potential index lesion radiated, it must have progressed post radiation therapy to be used as a measurable eligibility lesion
    • Patients may not have received prior MEK, v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), or v-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor therapy
    • Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:
    • Patients may not be receiving any other anti-cancer or investigational agents
    • The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to St. John's Wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
    • Patients with known leptomeningeal or brain metastases or spinal cord compression should be excluded from this clinical trial
    • Patients with a bowel obstruction or any other gastrointestinal condition that might affect absorption of the oral drug should be excluded; this would include patients with inability to swallow and retain orally-administered medication, malabsorption syndrome, or those with a major resection of the stomach or bowels
    • Patients with a history of interstitial lung disease or pneumonitis
    • Patients with a previous or current malignancy at other sites should be excluded, with the exception of:
    • Curatively treated local tumors such as carcinoma-in-situ of the cervix, basal or squamous cell carcinoma of the skin
    • Tumors for which no relapse has been observed within 5 years
    • Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications
    • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to dimethyl sulfoxide (DMSO), or to Cremophor EL (polyoxyethylated castor oil); please note, exclusion for Cremophor is unnecessary unless paclitaxel is the only agent available and the patient randomizes to the conventional therapy option
    • Patients with a history or evidence of cardiovascular risk, including any of the following:
    • Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN)
    • Bazett's corrected QT (QTcB) >= 480 msec
    • History or evidence of current clinically significant uncontrolled arrhythmias
    • Exception: Subjects with controlled atrial fibrillation for > 30 days prior to randomization are eligible
    • History of (within 6 months prior to randomization) acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting
    • History or evidence of current >= class II congestive heart failure as defined by New York Heart Association (NYHA)
    • Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy
    • Patients with intra-cardiac defibrillators or permanent pacemakers
    • Known cardiac metastases
    • Patients with a history or current evidence/risk of retinal vein occlusion (RVO)
    • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
    • Patients who require use of a concomitant medication that can prolong the QT interval
    • Animal reproductive studies have not been conducted with trametinib; therefore, the study drug must not be administered to pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer

    Protocol: OSU-13117

    Eligibility:

    Inclusion Criteria:

    • Patients must have histologically or cytologically confirmed metastatic invasive breast cancer that is negative for the estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor 2 (HER2) by institutional guidelines
    • Patients must have measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1])
    • Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer
    • Patients must consent to both a pretreatment and a post-treatment mandatory research biopsy prior to enrolling on trial, and therefore, must have tissue (excluding bone or brain) that is amenable to biopsy
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Life expectancy of greater than 3 months
    • Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
    • All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) grade =< 1 (except alopecia) at the time of enrollment
    • Absolute neutrophil count >= 1,500/mcL
    • Platelets >= 75,000/mcL
    • Total bilirubin =< 1.5 × institutional upper limit of normal
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal
    • Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
    • Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
    • Patients must have controlled blood pressure with a systolic blood pressure < 140 mmHg and diastolic < 90 mmHg; anti-hypertensive medications are permitted
    • Patients must be at least 4 weeks from last radiation dose; patients must be at least 4 weeks from last chemotherapy, targeted therapy, or biologic therapy; patients must be at least 4 weeks from last surgical procedure and recovered from all post-operative complications
    • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trametinib monotherapy or in combination with GSK2141795 administration
    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • History of another malignancy
    • Exception: Patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible
    • History of interstitial lung disease or pneumonitis
    • History of type I diabetes mellitus; if a patient has type II diabetes, they must have a glycosylated hemoglobin (hemoglobin A1C) =< 8%; patients with a screening fasting glucose > 120 mg/dL will be excluded
    • Uncontrolled hypothyroidism; patients must have a normal thyroid-stimulating hormone (TSH) per institutional standards at baseline
    • Patients who are receiving any other investigational agents
    • Individuals with symptomatic or progressive brain metastases are ineligible; subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for >= 3 weeks after completion of local therapy; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 3 weeks prior to study enrollment
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to trametinib monotherapy or trametinib in combination with GSK2141795
    • Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:
    • Other anti-cancer therapy while on study treatment (megestrol if used as an appetite stimulant is allowed)
    • The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], gingko biloba, yohimbe, saw palmetto, or ginseng)
    • Patients receiving strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
    • History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, history of hyperviscosity or hypercoagulability syndromes; visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mm Hg
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    • Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with trametinib monotherapy or trametinib in combination with GSK2141795
    • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

    Principal Investigator: Bhuvaneswari Ramaswamy, MD

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  • open for enrollment

    Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan &amp; Gemcitabine vs Placebo &amp; Gemcitabine in Metastatic Pancreatic Cancer

    Protocol: OSU-13268

    Eligibility:

    Inclusion Criteria:

    • Histologically or cytologically confirmed adenocarcinoma of the pancreas
    • Metastatic disease
    • Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
    • At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
    • Completed at least one cycle of the treatment
    • Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
    • Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
    • Progression was documented,
    • Preferentially radiologically by tumor growth or new lesions, or by
    • Clear symptomatic deterioration supported by at least two of the following clinical criteria: = 10% worsening in KPS or = 1 worsening in ECOG; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression.
    • KPS >/= 70
    • Adequate bone marrow function
    • Adequate hepatic function
    • Adequate renal function

    Exclusion Criteria:

    • CNS metastatic disease
    • Bulky disease (any single mass >10 cm).

    ->Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.

    • Prior external beam irradiation to a field that includes more than 30% of the red bone marrow.
    • Patients with clinically significant severe cardiorespiratory disease.

    Please consult with the clinical trial site for the full detailed list of specific inclusion/exclusion criteria.

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  • open for enrollment

    Methods Project 4: Clinical Trial

    Protocol: OSU-14104

    Eligibility:

    Inclusion Criteria: - Male or female subjects who are at least 18 years of age; - Daily smoker; - Generally good health; - Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products); Exclusion Criteria: - Unstable health - Pregnant or breastfeeding (due to toxic effects from tobacco products). - Unable to read for comprehension or completion of study documents.

    Principal Investigator: Peter Shields, MD

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  • open for enrollment

    Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer

    Protocol: OSU-12064

    Eligibility:

    Inclusion Criteria:

    • Patients must have histologically or cytologically confirmed papillary thyroid cancer, follicular thyroid cancer (tall cell variant, insular thyroid cancer, follicular variant of papillary thyroid cancers, poorly differentiated thyroid cancer or any of the above mixed histology will be allowed)
    • Presence of BRAF mutation in tumor tissue
    • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; malignant lymph nodes will be considered measurable if they are >= 15 mm in short axis
    • Patients must have progressive disease within the thirteen months prior to study entry; progressive disease is as defined in Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, which is at least a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5 mm; the appearance of one or more new lesions is also considered progressive disease
    • Patients are willing to have tumor biopsy pre-study and at 4 weeks on study (fine needle aspiration or core biopsy) if patient has biopsy-accessible tumors as determined by investigator
    • Patients must have disease that is refractory (unresponsive) to radioactive iodine (RAI) treatment as defined by one of the following:
    • One or more measurable lesions that do not demonstrate RAI uptake
    • One or more measurable lesions progressive by RECIST 1.1 within 12-months of prior RAI therapy
    • Cumulative RAI dose of > 600 mCi
    • Prior therapy allowed:
    • Patients may have been previously treated with up to three regimens of oral multikinase inhibitors, including sorafenib, sunitinib and pazopanib
    • Patients may have been previously treated with external beam radiation or cytotoxic chemotherapy therapy
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
    • Absolute neutrophil count >= 1,500/mcL
    • Platelets >= 100,000/mcL
    • Total bilirubin =< 1.5 X institutional upper limit of normal
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
    • Serum creatinine =< 1.5 X institutional upper limit of normal
    • Left ventricular ejection fraction (EF) >= institutional lower limit of normal
    • Patient must have a calcium phosphate product (CPP) =< 4.0 mmol^2/L^2 (50 mg^2/dL^2)
    • Female patients of childbearing age are required to have a negative serum pregnancy test within 14 days prior to the first dose of study medication
    • Females are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 4 weeks after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 16 weeks after completion of the last dose of study drug
    • Specific contraception requirements for females: female subjects of childbearing potential must not become pregnant and are required to be sexually inactive by abstinence or use contraceptive methods with a failure rate of < 1%; sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject; periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception; contraceptive methods with a failure rate of < 1% include the following:
    • Intrauterine device (IUD) or intrauterine system (IUS) that meets the < 1% failure rate as stated in the product label
    • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is patient's sole sexual partner; for this definition, "documented" refers to the outcome of the investigator's/qualified physician designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records
    • Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); these allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label; the investigator is responsible for ensuring subjects understand how to properly use these methods of contraception
    • Specific contraception requirements for males: to prevent pregnancy in a female partner or to prevent exposure of any partner to the investigational product from a male subject's semen, male subjects must use one of the following contraceptive methods during the study and for a total of 16 weeks following the last dose of study drug (based upon the lifecycle of sperm):
    • Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject for 14 days prior to first dose of study drug, through the dosing period, and for at least 16 weeks after the last dose of study drug; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    • Condom (during non-vaginal intercourse with any partner - male or female) OR
    • Condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) (during sexual intercourse with a female)
    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • Patients had external beam radiotherapy, cytotoxic chemotherapy, or oral multikinase inhibitors within 4 weeks prior to entering the study
    • Patients who have been treated with radioactive iodine within 24 weeks prior to entering the study (radioactive iodine within 4 weeks will be allowed if negative post-treatment scan)
    • Patients have not recovered from adverse events related to prior chemotherapy, radiation therapy or multikinase inhibitors to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 1 or less except for alopecia
    • Patients have been previously treated with potent BRAF inhibitor or MEK inhibitor, including PLX4032/vemurafenib, ARQ 736; previous treatment with sorafenib is permitted
    • Patients are receiving any other investigational agents
    • Patients are on any medication that is on the list of prohibitive medications; patients on therapeutic dose of warfarin; this is due to potential for significant interactions between warfarin and study agents
    • Patients with a known history of infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
    • Patients with a history of other malignancy; patients who have been disease-free from other malignancy for 5 years or greater, or patients with a history of resected non-melanoma skin cancer, or patients with a history of treated in situ carcinoma will be allowed
    • Patients with uncontrolled brain metastases; patients who are on a stable dose of corticosteroids for more than 1 month or off corticosteroids for 2 weeks can be enrolled; enzyme-inducing anti-epileptic drugs are not permitted
    • Patients with a known history of retinal vein occlusion or central serous retinopathy, or predisposing factors to retinal vein occlusion (RVO) or central serous retinopathy (CSR) (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
    • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
    • Evidence of new optic disc cupping
    • Evidence of new visual field defects
    • Intraocular pressure > 21 mm Hg as measured by tonography
    • Patients with a known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
    • Patients with class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
    • Abnormal cardiac valve morphology (subjects with minimal abnormalities, can be entered on study with approval)
    • Corrected QT (QTc) interval greater than or equal to 480 msecs (>= 500 msec for subjects with bundle branch block)
    • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    • Pregnant women and nursing women are excluded from this study
    • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
    • Subjects with a history of pneumonitis or interstitial lung disease
    • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 6 months
    • History of uncontrolled arrhythmias; subjects with controlled atrial fibrillation for > 1 month prior to study day 1 are eligible

    Principal Investigator: Manisha H. Shah, MD

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  • open for enrollment

    Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

    Protocol: NRG-HN001

    Eligibility:

    Inclusion Criteria:

    • Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
    • Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration
    • Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:
    • History/physical examination by a Medical Oncologist or Clinical Oncologist and/or Radiation Oncologist, which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration
    • Evaluation of tumor extent with magnetic resonance imaging (MRI) of the nasopharynx and neck within 28 days prior to registration; if MRI is medically contraindicated, obtain computed tomography (CT) scan with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement); Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist
    • To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:
    • A CT scan with contrast of the chest, abdomen, and/or pelvis or a total body positron emission tomography (PET)/CT scan
    • A bone scan when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
    • Zubrod performance status 0-1 within 21 days prior to registration
    • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
    • Platelets >= 100,000 cells/mm^3
    • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN
    • Alkaline phosphatase =< 1.5 x institutional ULN
    • Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula
    • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
    • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
    • Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay

    Exclusion Criteria:

    • Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
    • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin
    • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
    • Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss from tumor-related otitis media is allowed
    • >= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
    • Severe, active co-morbidity, defined as follows:
    • Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy
    • Unstable angina and/or uncontrolled congestive heart failure
    • Myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
    • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
    • Prior allergic reaction to the study drug(s) involved in this protocol
    • Patients with undetectable pre-treatment plasma EBV DNA
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  • open for enrollment

    Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

    Protocol: OSU-12223

    Eligibility:

    Inclusion Criteria:

    • Histological diagnosis of NSCLC or MPM; pts must have clinical and/or pathological evidence of pleural spread or stage III/IV MPM
    • Pts with NSCLC who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated
    • Assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with NSCLC and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement
    • Assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma
    • All studies required for evaluation will be performed within 8 weeks of Photofrin administration
    • Pts of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group
    • ELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATION
    • Pts undergoing extrapleural pneumonectomy without PDT for MPM or stage IV (M1A) NSCLC (after American Joint Committee on Cancer [AJCC] staging change 2010) or stage IIIB (before staging change) with malignant pleural effusion treated at Ohio State University (OSU) from 2005-2012
    • Historical control data will be derived from patient medical records at the Ohio State University Medical Center (OSUMC)

    Exclusion Criteria:

    • Pts who have grade III-IV elevations in liver transaminases (as defined by the Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.0) or a bilirubin in excess of 1.5 mg/dl
    • Pts who are medically unfit to tolerate surgery
    • Pts with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) disease (routine testing is not needed if not clinical indicated)
    • Pregnant or lactating pts
    • Prior treatment for NSCLC except for pleurodesis and/or standard frontline chemotherapy
    • Pts who have received prior mantle or extensive mediastinal radiation
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  • open for enrollment

    Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease

    Protocol: OSU-14094

    Eligibility:

    Inclusion Criteria: - Steroid dependent or refractory classic chronic GVHD disease. - No more than 3 previous treatments for cGVHD. - Receiving baseline systemic glucocorticoid therapy (at stable dose) for cGVHD at study entry. - Men and women =18 years old. - Karnofsky performance status =60. Exclusion Criteria: - Known or suspected active acute GVHD. - Current treatment with sirolimus AND either cyclosporine or tacrolimus. - History of treatment with a tyrosine kinase inhibitor (eg, imatinib), purine analogs or other cancer chemotherapy in the 4 weeks prior to starting study drug. - Currently active, clinically significant cardiovascular disease. - Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed =14 days before the first dose of study drug. - Progressive underlying malignant disease including post-transplant lymphoproliferative disease. - History of other malignancy (not including the underlying malignancy that was the indication for transplant) - Concomitant use of warfarin or other Vitamin K antagonists - Known bleeding disorders or hemophilia. - History of stroke or intracranial hemorrhage within 6 months prior to enrollment. - Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). - Concurrent use of a strong cytochrome P450(CYP) 3A inhibitor

    Principal Investigator: Samantha M Jaglowski, MD, Affiliate

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  • open for enrollment

    ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma

    Protocol: OSU-14003

    Eligibility:

    Inclusion Criteria:

    • Must have a documented diagnosis of multiple myeloma and have relapsed-and-refractory disease. Patients must have received at least 2 lines of prior therapies. Patients must have relapsed after having achieved at least stable disease (SD) for at least one cycle of treatment to at least one prior regimen and then developed progressive disease (PD). Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease)
    • Must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
    • Must not be a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT
    • Must have measurable levels of myeloma paraprotein in serum (= 0.5 g/dL) or urine (= 0.2 g/24 hours)
    • Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
    • Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to, and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods,and Education and Counseling Guidance must be followed per protocol
    • Must be able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an international normalized ratio (INR) of 2 to 3

    Exclusion Criteria:

    • Pregnant or lactating females
    • Prior therapy with HDAC inhibitor
    • Any of the following laboratory abnormalities:
    • ANC < 1,000/µL
    • Platelet count < 75,000/ µL for patients in whom < 50% of bone marrow nucleated cells are plasma cells; and < 50,000/ µL for patients in whom = 50% of bone marrow nucleated cells are plasma cells
    • Hemoglobin < 8g/dL (<4.9 mmol/L; prior red blood cell [RBC] transfusion is permitted)
    • Creatine clearance < 45mL/min according to Cockcroft-Gault formula. If creatine clearance calculated from the 24-hour urine sample is = 45 mL/min, patient will qualify for the study
    • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), or serum glutamic pyruvic transaminase (SGPT)/ alanine aminotransferase (ALT) > 3.0 × ULN
    • Serum total bilirubin > 2.0 mg/dL
    • Prior history of malignancies, other than MM, unless the patient has been free of the disease for = 3 years. Exceptions include the following:
    • Basal or squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix or breast
    • Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
    • Corrected QT interval using Fridericia's formula (QTcF) value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG)
    • Positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
    • Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (such as Steven Johnson Syndrome). Hypersensitivity, such as rash, that can be medically managed is allowable
    • Peripheral neuropathy = Grade 2 desipite supportive therapy
    • Radiotherapy or systemic therapy (standard or an investigational or biologic anticancer agent) within 14 days of initiation of study drug treatment
    • Current enrollment in another clinical trial involving treatment and/or is receiving an investigational agent for any reason
    • Inability or unwillingness to comply with birth control requirements or regional REMS/RevAid programs

    Principal Investigator: Ashley Rosko, MD

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  • open for enrollment

    Safety &amp; Efficacy Study of TPI 287 + Avastin in Adults With Glioblastoma That Progressed Following Prior Avastin Therapy

    Protocol: OSU-14195

    Eligibility:

    Inclusion Criteria:

    1. Histologically proven GBM

    2. Disease progression following radiation & TMZ

    3. 1st progression of GBM on bevacizumab-containing regimen or within 8 weeks of discontinuing bevacizumab. In either case, must have received a minimum of 8 weeks (4 infusions) of bevacizumab.

    4. Baseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, & on steroid dosage that has been stable or decreasing for at least 5 days

    5. Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery & subject has recovered from surgery

    6. Life expectancy >12 weeks

    7. Eighteen years old or older

    8. KPS equal to or greater than 70

    9. Recovered from toxic effects of prior therapy to < Grade 2 toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy & Day 1 is:

    1. At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks

    2. 4 weeks from prior cytotoxic therapy

    3. 4 weeks from prior experimental drug

    4. 6 weeks from nitrosoureas

    5. 3 weeks from procarbazine

    6. 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen, & cis-retinoic acid)

    7. 14 days from last dose of bevacizumab

    10. Adequate bone marrow function [absolute neutrophil count (ANC) > 1,500/mm3 & platelet count of > 100,000/mm3], adequate liver function [alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <3 x upper limit normal (ULN), alkaline phosphatase <2 x ULN, & total bilirubin <1.5 mg/dL], & adequate renal function (BUN & creatinine <1.5 x ULN)

    11. Minimum hemoglobin of 9 g/dL

    12. Males & women of childbearing potential must agree to abstain from sex or use an adequate method of contraception for duration of study & for 6 months after last dose of study drug

    13. Signed & dated ICF prior to Screening evaluations

    Exclusion Criteria:

    1. Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor

    2. Evidence or suspicion of disease metastatic to sites remote from supratentorial brain

    3. Prior treatment with anti-vascular endothelial growth factor (VEGF) drugs other than bevacizumab

    4. Prior treatment with tyrosine-kinase inhibitors targeting VEGF, platelet-derived growth factor, fibroblast growth factor, tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 (TIE-2), or angiopoietin (or their receptors)

    5. Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors

    6. Prior treatment with TPI 287

    7. Treatment with Enzyme-Inducing Anti-Epileptic Drugs within 2 weeks prior to Day 1

    8. Treatment with drugs or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4 or 2C8 within 2 weeks prior to Day 1

    9. Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, dose counts against total dose limit.

    10. Prior taxane, vincristine, or other microtubule inhibitor chemotherapies for treatment of GBM or other malignancy

    11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during course of study

    12. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1

    13. Any condition, including the presence of clinically significant laboratory abnormalities, which places subject at unacceptable risk if he/she were to participate in study or confounds the ability to interpret data from study, including:

    1. Active infection including known AIDS or Hepatitis C or with a fever =38.5°C within 3 days prior to study enrollment

    2. Diseases or conditions that obscure toxicity or dangerously alter drug metabolism

    3. Serious intercurrent medical illness (e.g., symptomatic congestive heart failure)

    14. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent subject from providing informed consent

    15. Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg)

    16. Prior history of hypertensive crisis or hypertensive encephalopathy

    17. New York Heart Association Grade II or greater congestive heart failure

    18. History of myocardial infarction or unstable angina within 6 months prior to Day 1

    19. History of stroke or transient ischemic attack within 6 months prior to Day 1

    20. Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1

    21. History of hemoptysis (= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1

    22. Evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation)

    23. Grade 2 or higher peripheral neuropathy per NCI CTCAE

    24. History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1

    25. Serious, non-healing wound, active ulcer, or untreated bone fracture

    26. Proteinuria at Screening. Subjects with a urine dipstick protein = 2+ at Screening will undergo a 24-hour urine collection and must demonstrate = 1g of protein in 24 hours to be eligible.

    27. Known hypersensitivity to any inactive ingredient of bevacizumab

    28. Known hypersensitivity to any inactive ingredient of TPI 287

    29. Pregnancy (positive pregnancy test) or lactation

    30. Inability to comply with protocol or study procedures

    31. Previously or currently enrolled in Protocol No. TPI-287-17

    Principal Investigator: Pierre Giglio, MD, Affiliate

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