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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

    ACP-196, a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

    Protocol: OSU-14111

    Eligibility:

    Inclusion Criteria:

    • Men and women = 18 years of age.
    • Pathologically confirmed de novo ABC DLBCL
    • Relapsed or refractory disease
    • Subjects must have = 1 measurable disease sites

    Exclusion Criteria:

    • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk
    • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 40%
    • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
    • Breast feeding or pregnant
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  • open for enrollment

    Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)

    Protocol: BMT-CTN0702

    Eligibility:

    Inclusion Criteria:

    • Patients meeting the criteria for symptomatic multiple myeloma (MM).
    • Patients who are 70 years of age, or younger, at time of enrollment.
    • Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 - 12 months of the first dose of initial therapy.
    • Cardiac function: left ventricular ejection fraction at rest greater than 40 percent.
    • Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.)
    • Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated.
    • Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin).
    • Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight.
    • Signed informed consent form.

    Exclusion Criteria:

    • Patients who never fulfill the criteria for symptomatic MM.
    • Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
    • Patients with plasma cell leukemia.
    • Karnofsky performance score less than 70 percent.
    • Patients with greater than grade 2 sensory neuropathy (CTCAE).
    • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
    • Patients seropositive for the human immunodeficiency virus (HIV).
    • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
    • Patient has hypersensitivity to bortezomib, boron or mannitol.
    • Patient has received other investigational drugs with 14 days before enrollment.
    • Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years previously is allowed.
    • Female patients who are pregnant (positive B-HCG) or breastfeeding.
    • Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
    • Prior allograft or prior autograft.
    • Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy.
    • Patients unable or unwilling to provide informed consent.
    • Prior organ transplant requiring immunosuppressive therapy.
    • Patients with disease progression prior to enrollment.
    • Patients who have received lenalidomide as initial therapy for MM and have experienced toxicities resulting in treatment discontinuation.
    • Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide.
    • Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.
    • Patients who cannot undergo an intervention in any treatment arm due to a priori denial of medical costs coverage by third party payers.
    • Patients unable to unwilling to return to the transplant center for their assigned treatments.

    Principal Investigator: Yvonne A Efebera, MD, Affiliate

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  • open for enrollment

    Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

    Protocol: OSU-14171

    Eligibility:

    Inclusion Criteria:

    • =18 years of age
    • Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for treatment (Binet Stage = B and/or Rai Stage = I with symptoms)
    • Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)
    • Relapsed or refractory disease while receiving a BTKi therapy, which must be the subject's most recent prior anticancer therapy:
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status [KPS] =60%)
    • Subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period

    Exclusion Criteria:

    • Richter's transformation or prolymphocytic leukemia
    • Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
    • Prior exposure to a PI3K inhibitor (e.g. GS-1101 [idelalisib], duvelisib)
    • History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)
    • Human immunodeficiency virus (HIV) or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
    • Prior, current, or chronic hepatitis B or hepatitis C infection
    • History of tuberculosis treatment within the preceding 2 years
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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

    Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer

    Protocol: NRG-HN002

    Eligibility:

    Inclusion Criteria:

    • STEP 1: REGISTRATION
    • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx; clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)
    • Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations; tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site; limited neck dissections retrieving =< 4 nodes are permitted and considered as non-therapeutic nodal excisions
    • Immunohistochemical staining for p16 must be performed on tissue, and this tissue must be submitted for central review; fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is available for p16 immunohistochemistry; FNA specimens prepared with adequate p16 testing in this manner are acceptable to submit for central review; if the p16 preparation is not adequate, additional specimens will be required to establish p16 status; centers are encouraged to contact the pathology chairs for clarification
    • Clinical stage T1-T2, N1-N2b or T3, N0-N2b (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) including no distant metastases based on the following diagnostic workup:
    • General history and physical examination within 56 days prior to registration
    • Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 70 days prior to registration
    • One of the following combinations of imaging is required within 56 days prior to registration:
    • A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast)
    • Or a magnetic resonance imaging (MRI) of the neck (with contrast) and a chest CT scan (with or without contrast)
    • Or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast)
    • Or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast)
    • Note: a CT scan of neck and/or a PET/CT performed for the purpose of radiation planning may serve as both staging and planning tools
    • Patients must provide their personal smoking history prior to registration; the lifetime cumulative history cannot exceed 10 pack-years; the following formula is used to calculate the pack-years during the periods of smoking in the patient's life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history
    • Number of pack-years = (frequency of smoking [number of cigarettes per day] x duration of cigarette smoking [years])/20
    • Note: twenty cigarettes is considered equivalent to one pack; the effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined; cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years; however, investigators are discouraged from enrolling patients with a history of very sustained use of non-cigarette tobacco products alone
    • While there are increased risks of head and neck cancer associated with sustained heavy cigar and pipe use, such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking
    • Zubrod performance status of 0-1 within 56 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
    • Serum creatinine =< 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
    • Bilirubin =< 2 mg/dl
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x the upper limit of normal
    • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
    • Patients who are human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS)-defining illness and have cluster of differentiation (CD)4 cells of at least 350/mm^3 are eligible; HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions; patients must not be seropositive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or seropositive for hepatitis C (anti-hepatitis C antibody positive); however, patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
    • The patient must provide study-specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review
    • Patients who speak English (or read one of the languages for which a translation is available must consent to complete the mandatory dysphagia-related patient reported instrument (MDADI); if the patient cannot understand spoken English and reads only languages not available in the MDADI translations, the patient can still participate in the trial, as this has been factored into the trial statistics; for all other patients, the MDADI is mandatory as it is included in the primary endpoint to be studied
    • STEP 2: RANDOMIZATION
    • p16 positive by immunohistochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells, confirmed by central pathology review)

    Exclusion Criteria:

    • STEP 1 (REGISTRATION)
    • Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive
    • Carcinoma of the neck of unknown primary site origin (even if p16 positive)
    • Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane
    • Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle
    • Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
    • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
    • Simultaneous primary cancers or separate bilateral primary tumor sites
    • Prior invasive malignancy (except 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
    • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
    • Severe, active co-morbidity defined as follows:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
    • Pregnancy
    • Prior allergic reaction to cisplatin

    Principal Investigator: Maura L Gillison, MD, PhD

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  • open for enrollment

    A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

    Protocol: OSU-14229

    Eligibility:

    Inclusion Criteria:

    • All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)
    • Eastern Cooperative Oncology Group status of 0 or 1
    • Adequate baseline renal and hepatic function
    • Central venous access
    • Part specific requirements: eligible to receive induction; achieved CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance

    Exclusion Criteria:

    • Previous treatment for MDS or MPN for dose escalation cohorts
    • Inadequate lung function
    • Inadequate heart function

    Principal Investigator: Sumithira Vasu, MD

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  • open for enrollment

    Gemcitabine Hydrochloride and Cisplatin With or Without Radiation Therapy in Treating Patients With Localized Liver Cancer That Cannot Be Removed by Surgery

    Protocol: NRG-GI001

    Eligibility:

    Inclusion Criteria:

    • Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma (IHC) without distant extrahepatic metastasis within 30 days of registration
    • Patient must have 1 lesion with a maximum AXIAL diameter of 12 cm; up to 3 satellite lesions are permitted; satellite lesions, are defined as lesions less than 2 cm that are within 1 cm of the periphery of the dominant lesion (GTV) are permitted; the satellite lesions are NOT included in the AXIAL diameter measurement; regional lymph node involvement within the porta hepatis (as medial as superior mesenteric vein [SMV] portal vein confluence) is permitted if nodes are deemed clinically positive (i.e. fludeoxyglucose F 18 [FDG] avid)
    • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
    • History/physical examination within 30 days prior to registration
    • Assessment by medical oncologist who specializes in treatment of IHC within 30 days of registration
    • Pre-randomization scan (REQUIRED for all patients): computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan within 30 days prior to registration; if CT contrast is contraindicated, CT chest without contrast and magnetic resonance imaging (MRI) of abdomen and pelvis is permitted
    • Zubrod performance status 0-1 within 30 days prior to registration
    • Absolute neutrophil count (ANC) >= 1,500 cells/m^3
    • Platelets >= 100,000 cells/mm^3
    • Total bilirubin =< 2.5 mg/dl
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 X institutional upper limit of normal
    • Albumin >= 2.5 mg/dl
    • Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m^2 for subject with creatinine levels above institutional normal
    • Hemoglobin >= 9.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)
    • Patient must provide study specific informed consent prior to study entry
    • Negative beta human chorionic gonadotropin (bHCG) within 14 days prior to study entry if patient is pre or perimenopausal

    Exclusion Criteria:

    • Multiple lesions that don't meet the criteria as satellite lesions
    • Extrahepatic metastases or malignant nodes beyond the periportal region; celiac, pancreaticoduodenal and para-aortic nodes > 2 cm are ineligible; note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm
    • Maximum diameter exceeding 12 cm (maximum diameter does not include satellite lesion)
    • Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 60 days prior to study entry
    • Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
    • Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
    • Direct tumor extension into the stomach, duodenum, small bowel or large bowel
    • Measureable common or main branch biliary duct involvement with hepatocellular carcinoma (HCC)
    • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (note: carcinoma in situ of the breast, oral cavity, or cervix is all permissible)
    • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
    • Currently receiving other anti-cancer agents
    • Participants who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin
    • Prior surgery for the IHC; (liver resection is not allowed)
    • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
    • Prior allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine (gemcitabine hydrochloride) or cisplatin
    • Severe, active co-morbidity, defined as follows:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
    • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
    • End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
    • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
    • Grade 3 or higher peripheral neuropathy

    Principal Investigator: Evan J Wuthrick, MD

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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 Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes

    Protocol: OSU-14225

    Eligibility:

    Inclusion Criteria:

    • Diagnosis of urothelial carcinoma
    • Metastatic or locally advanced disease
    • Prior chemotherapy that included a platinum agent
    • Test results showing genetic change in tumor gene for CREBBP and/or EP300
    • At least one tumor that can be measured

    Exclusion Criteria:

    • Uncontrolled tumor in the brain
    • Impaired heart function

    Principal Investigator: Amir Mortazavi, MD, Affiliate

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  • open for enrollment

    Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer

    Protocol: OSU-14250

    Eligibility:

    Inclusion Criteria:

    1. Subject is male or female, = 18 years old at the time of signing the informed consent form (ICF).

    2. Subject has a confirmed diagnosis of advanced unresectable solid tumors in the target subject population within the parameters mentioned:

    1. Pancreatic Cancer

    • Subject has a definitive histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas. Subjects with islet cell neoplasms are excluded.
    • nab-Paclitaxel and Nivolumab: Subjects must have received 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease.
    • nab-Paclitaxel + Nivolumab and nab-paclitaxel , Gemcitabine and Nivolumab : Subjects must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease. Subjects having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for inclusion. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, but = 6 months must have elapsed since completion of the last dose and no lingering toxicities may be present. Initial diagnosis of metastatic disease must have occurred =6 weeks prior to randomization in the study.

    2. Non-small Cell Lung Cancer (NSCLC):

    • Subject has definitive histologically or cytologically confirmed Stage IIIB or IV NSCLC.
    • Subjects must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed > 12 months prior to randomization, without disease recurrence or progression during those 12 months.

    3. Recurrent Metastatic Breast Cancer: Human Epidermal Growth Factor Receptor 2 - negative (HER2(-)) recurrent metastatic Breast Cancer:

    • Subject has a definitive histologically or cytologically confirmed diagnosis of HER2(-) metastatic breast cancer.
    • Subject has received one prior cytotoxic chemotherapy regimen for metastatic disease, including an anthracycline unless clinically contraindicated. (Clinically contraindicated is defined as unless: [a.] anthracycline treatment was not indicated or was not the best treatment option for the subject in the opinion of the treating physician; and [b.] anthracycline treatment remains not indicated or, in the opinion of the treating physician, is not the best treatment option for the subject's metastatic disease.)
    • If subject has received solvent-based paclitaxel (TAXOL) or docetaxel as adjuvant chemotherapy, subject must not have relapsed with breast cancer within 12 months of completing said therapy.
    • Suitable candidate for single agent nab-paclitaxel as assessed by the investigator. Subject has measurable disease according to RECIST 1.1.

    3. Archival formalin-fixed, paraffin-embedded tumor sample collected within 90 days prior to subject consent available or subject has biopsiable metastatic lesion and is willing to undergo biopsy .4. Subject has no other malignancy within 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in-situ cervical cancer.

    5. Subject has the following laboratory values at screening:

    • WBCs = 2000/uL,
    • Absolute neutrophil count (ANC) = 1.5 x 109/L,
    • Hemoglobin (Hgb) = 90 g/L,
    • Platelets (plt) = 100 x 109/L,
    • Potassium within normal range, or correctable with supplements,
    • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 2.5 x Upper Limit of Normal (ULN) or = 3.0 x ULN if liver tumor is present,
    • Serum total bilirubin = 1.5 x ULN (except in subjects with Gilbert's who may have serum bilirubin < 3.0 x ULN),
    • Serum creatinine = 1.5 x ULN, or 24-hr clearance = 60 mL/min,
    • Normal coagulation [prothrombin time and partial thromboplastin time within normal limits (±15%)].

    6. Subject has resting baseline oxygen saturation by pulse oximetry of = 92% at rest.

    7. Females of child-bearing potential (defined as a sexually mature woman who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or, 2) has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months) must:

    1. Agree in writing to use, and be able to comply with, highly effective contraception (failure rate less than 1% per year) based on Appendix B without interruption while on study treatment and for 23 weeks after discontinuation; and

    2. Have a negative serum pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of ß -hCG (Beta Subunit of Human Chorionic Gonadotropin)) at screening and 24 hours prior to the start of any IP and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.

    3. Women must not be breastfeeding. (Females should not be breastfeeding while receiving nivolumab and up to 18 weeks from the last dose of nivolumab).

    8. Male subjects agree in writing to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 31 weeks following IP discontinuation, even if he has undergone a successful vasectomy.

    9. Subject or his/her legally authorized representative or guardian understands and voluntarily signs an informed consent document prior to any study related assessments/procedures are conducted (except as noted in Section 6).

    10. Subject is able to adhere to the study visit schedule and other protocol requirements.

    Exclusion Criteria:

    1. Subject has a history of allergy or hypersensitivity to any study drugs or their excipients.

    2. Subject has symptomatic brain metastases, spinal cord compression, or intractable back pain due to compression of destructive mass.

    3. Subject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa or auto-immune hepatitis. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

    4. Subject is currently receiving or requires treatment with immunosuppressive agents or immunosuppressive doses of systemic corticosteroids (unless used to treat drug-related adverse events).Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption), and some uses of systemic corticosteroids are permitted as per Section 9.1.

    5. Subject has any peripheral neuropathy = NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events ) Grade 2 at randomization/enrollment.

    6. Subject has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies. Any lung disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.

    7. Subject has a high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.

    8. Subject has unstable angina, a significant cardiac arrhythmia, or New York Heart Association Class 3 or 4 congestive heart failure.

    9. Subject has a history of peripheral artery disease (eg, claudication, Leo Buerger's disease).

    10. Subject has had major surgery, other than diagnostic surgery, within 4 weeks prior to treatment in study.

    11. Subject has known acute or chronic pancreatitis.

    12. Subject has persistent diarrhea, malabsorption, or known sub-acute bowel obstruction = NCI CTCAE Grade 2, despite medical management.

    13. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

    14. Subject has any history of testing positive for Human Immunodeficiency Virus (HIV) or known acquired immunodeficiency disorder (AIDS).

    15. Subject has historical or active infection with hepatitis B, or hepatitis C.

    16. Subject is pregnant or breast-feeding.

    17. Subject is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.

    18. Subject is currently using or use within 6 months of illicit drugs.

    19. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

    20. Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.

    21. Subject has any condition that confounds the ability to interpret data from the study.

    Principal Investigator: Tanios Bekaii-Saab, MD

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