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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

    Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

    Protocol: OSU-07061

    Eligibility:

    Inclusion Criteria:

    • Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
    • Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
    • Written informed consent and/or Consent waiver by institutional review board (IRB)

    Exclusion Criteria:

    • Unexplained fever and/or untreated, active infection
    • Patient pregnancy
    • Previous head and neck surgery precluding transoral/robotic procedures
    • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
    • Inability to grant informed consent
    • INTRAOPERATIVE EXCLUSION CRITERIA:
    • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
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  • open for enrollment

    Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

    Protocol: OSU-13079

    Eligibility:

    PARTICIPANT SELECTION

    • Risk Level Required for RPFNA Screening for Eligibility
    • Given the low probability of side effects and the desire to be able to generalize results to a moderate as well as high risk population, the target cohort is pre-menopausal women who have a relative risk for breast cancer which is 2-fold or greater than that of the average woman in their age group by virtue of any one of the following conditions:
    • A 1st or 2nd degree relative with breast cancer diagnosed under the age of 60
    • A prior biopsy indicating proliferative breast disease, atypical hyperplasia, or LCIS
    • Multiple prior breast biopsies regardless of histology
    • 50% or higher estimated mammographic density on visual inspection
    • Prior or current RPFNA evidence of atypia
    • Known carrier of a BRCA1 or 2 mutation.
    • Age, Life-Style and Medical Eligibility Criteria for Tissue Screening

    Candidates for tissue screening for this study are pre-menopausal women who meet the risk criteria above and all of the following demographic and medical criteria:

    • Age 21 to 49 (limiting the maximum age to 49 will reduce the possibility of reduction in Ki-67 due to entry into menopause transition during the study).
    • Stable hormonal status for the previous 6 months (has not stopped or started oral contraceptives, or experienced lactation or pregnancy) and willing to maintain same status while on study.
    • BMI < 40 kg/m2.
    • Has had at least 4 menstrual cycles in past year
    • If regularly undergoing screening mammography, must have been performed within 9 months prior to baseline RPFNA, and interpreted as not suspicious for breast cancer
    • Breast exam interpreted as normal (not suspicious for cancer).
    • Exclusion Criteria for Screening RPFNA and Study Participation

    Candidates are ineligible for tissue screening if they meet any of the following conditions:

    • Consumption of systemic antibiotics during the 3 weeks prior to baseline RPFNA. Systemic antibiotics reduce intestinal bacteria and thus the ability to convert SECO to ENL [104].
    • Consumption of supplements containing SDG (flaxseed or sesame seed) during the 3 weeks prior to baseline RPFNA. ( Consumption of foods containing flaxseed or sesame seed are OK.)
    • Use of any selective estrogen receptor modulator or aromatase inhibitor (tamoxifen, raloxifene, arzoxifene, acolbifine, anastrozole, exemestane, letrozole) within the previous 6 months.
    • Currently enrolled on an interventional investigational study.
    • Bilateral breast implants.
    • Invasive breast cancer or other invasive cancer diagnosis within five years.
    • Metastatic malignancy of any kind.excluding Hodgkin's or non-Hodgkin's lymphoma.
    • Current anticoagulant use.
    • Consumption of coumadin, fish oil, or other anticoagulants during the 3 weeks prior to baseline RPFNA.
    • Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for RPFNA or the trial.
    • Inclusion Criteria for Study Entry
    • RPFNA performed in the follicular portion (day 1-10) of the menstrual cycle. Note that day 1 is defined as the first day of bleeding.
    • RPFNA specimen exhibits hyperplasia +/- atypia (Masood score of =13) with =500 cells on the cytology slide.
    • Ki-67 =2% positivity (=500 cells).
    • Willing to continue without oral contraceptives throughout the duration of the study participation (12 months). Non-oral contraceptives are permissible. If heterosexually active, must be agreeable to use some non-hormonal form of contraception during the trial or husband or partner must have had a vasectomy. (Safety of SDG during pregnancy has not been documented).
    • Have reasonable organ function as documented by metabolic chemistry profile.
    • Willing to undergo a history and physical at baseline and 12 months and be contacted periodically by the trial coordinator during the 12 month study period.
    • Willing to have blood drawn at baseline and twelve months.
    • Able to understand and willing to provide informed consent for the RPFNA's and study participation.

    Principal Investigator: Lisa D Yee, MD

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  • open for enrollment

    Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer

    Protocol: OSU-13034

    Eligibility:

    INCLUSION CRITERIA:

    • Increased risk for breast cancer based on family history, personal history
    • Normal mammogram, clinical breast examination in the past 12 months
    • >1 year from pregnancy, lactation or chemotherapy
    • Body mass index (BMI) between 30 - 40

    EXCLUSION CRITERIA:

    • Concurrent malignancy or metastatic malignancy of any kind
    • Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
    • History of a bleeding tendency or current use of Coumadin or other anticoagulants
    • Current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (HIV) infection
    • Pregnant or lactating women
    • Concurrent use of hormonal contraception or hormone replacement therapy
    • Concurrent use of immunosuppressant medications
    • Concurrent use of antacids, hydrogen (H2) antagonists, proton-pump inhibitors, or medications known to inhibit or induce hepatic enzyme cytochrome P450 (CYP) 3A4
    • Barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (FNA) sampling
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements
    • Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with NEC
    • Known sensitivity or allergy to turmeric spices or curry
    • Dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis
    • Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (NSAID)s or NSAID-containing products

    Principal Investigator: Lisa D Yee, MD

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  • open for enrollment

    Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

    Protocol: OSU-13053

    Eligibility:

    Inclusion Criteria:

    1. A histologically or cytologically confirmed diagnosis of cancer

    2. Patients with any malignancy.

    3. Patients must have tumor suitable for research tumor biopsy (as assessed by trained specialists in interventional radiology) and Patients are medically fit to undergo a tissue biopsy or surgical procedure to get tumor tissue OR If Patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation.

    OR Patients are undergoing standard of care surgeries or procedures where fresh specimens will be first used for routine pathologic assessment and only then will leftover tissue be used for research purposes.

    4. Procedure-specific signed informed consent prior to initiation of any study-related procedures.

    5. Women and minorities are included in this protocol.

    6. Patients with multiple malignancies remain eligible.

    7. Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible.

    Exclusion Criteria:

    1. It is the enrolling study physicians discretion to decide if a patient is not fit enough to undergo tissue biopsy.

    2. Patients who are incarcerated are not eligible to participate.

    Principal Investigator: Sameek Roychowdhury, MD, PhD

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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

    Ph 3 Stress Immunity & Breast Cancer Recurrence

    Protocol: OSU-9942

    Principal Investigator: Barbara L Andersen, PhD

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  • open for enrollment

    First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

    Protocol: OSU-13059

    Eligibility:

    Criteria for Selection of Patient Population Inclusion Criteria

    • Patients with advanced solid tumor that is refractory to standard treatment, for which no standard treatment is available, or the patient refuses standard therapy.
    • = 18 years old at the time of informed consent.
    • ECOG Performance Status 0 or 1.
    • Patients must have adequate hematologic and organ function.
    • Patients must be willing and able to sign the informed consent form, and to follow the study visit schedule and other protocol requirements.
    • Women of childbearing potential and men must agree to use effective contraceptive methods while on study and for at least twelve weeks after the last dose of study drug.
    • Women of childbearing potential must have a negative pregnancy test prior to the first dose of study treatment.

    Exclusion Criteria

    • Grade >1 neuropathy
    • Any active or chronic corneal disorder, including Sjogren's syndrome.
    • Serious concurrent illness:
    • Any other concomitant anti-cancer treatment.
    • Women of childbearing potential who are pregnant or breast feeding.

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment

    Protocol: OSU-08078

    Eligibility:

    Inclusion Criteria:

    1. Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST

    2. Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation

    3. C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative

    4. Man or woman, age >18 years

    5. Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake

    6. Patient able and willing to comply with study procedures as per protocol

    7. Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures

    Exclusion Criteria:

    1. Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2

    2. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ

    3. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

    4. Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline) Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment

    5. Treatment with any investigational agent within 4 weeks prior baseline

    6. Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline

    Principal Investigator: Tanios Bekaii-Saab, MD

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  • open for enrollment

    3 Tesla MRI in Patients With Bladder Cancer

    Protocol: OSU-08063

    Eligibility:

    Inclusion Criteria:

    • Known bladder cancer
    • Scheduled for radical cystectomy and lymph node dissection.
    • Able and willing to give valid written informed consent.
    • No contraindications to the MRI(magnetic resonance imaging).

    Exclusion Criteria:

    • Not pregnant, planning to become pregnant during the study, or nursing.
    • No allergy to contrast agents.
    • Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate(eGRF) less than 30 mL/min/1.73m2.
    • Any condition conflict based on the investigation's clinical judgment that would prevent the patient from completion all trial assessments and visits.
    • Inability or unwillingness to cooperate with requirements of this trial.
    • Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR.
    • Patients with sickle cell anemia and other hemolytic anemia.

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care

    Protocol: OSU-08095

    Eligibility:

    Inclusion Criteria:

    • HIGH-RISK POPULATION:
    • 33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
    • GENERAL POPULATION:
    • 250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate
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