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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


    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
    • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
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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


    Inclusion Criteria:

    • 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
    • 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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  • open for enrollment

    3 Tesla MRI in Patients With Bladder Cancer

    Protocol: OSU-08063


    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

    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


    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 Finding Tumors in Patients With Known or Suspected Prostate Cancer

    Protocol: OSU-07042


    Inclusion Criteria:

    • Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleason's score >= 7 and prostate-specific antigen [PSA] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians
    • Written informed consent will be signed by the patients before the MRI based on the guidelines approved by the Ohio State University Institutional Review board
    • Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73m^2 within six weeks of the MRI to be included in the study

    Exclusion Criteria:

    • Patients with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
    • Patients with any type of ferromagnetic bioimplant that could potentially be displaced or damaged
    • Patients that have vascular or aneurysm clips, or metallic staples from a surgical procedure
    • Patients with permanent tattoo eye liner (may contain metallic coloring)
    • Patients that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims
    • Patients that exhibit noticeable anxiety and/or claustrophobia
    • Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher
    • Patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
    • Patients with an estimated glomerular filtration rate of < 30 mL/min/1.73m^2 within six weeks of the MRI
    • Acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73m^2)
    • Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

    Protocol: GOG-213


    Inclusion Criteria:

    • Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery and consent to have their surgical treatment determined by randomization
    • Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
    • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
    • Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles)
    • A complete response to front-line chemotherapy must include: negative physical exam, negative pelvic exam and normalization of CA125, if elevated at baseline; although not required, any radiographic assessment of disease status (e.g. CT, magnetic resonance imaging [MRI], positron emission tomography [PET]/CT, etc) obtained following the completion of primary therapy should be considered negative for disease
    • All patients must have also had a treatment-free interval without clinical evidence of progressive disease of at least 6 months from completion of front-line chemotherapy (both platinum and taxane); front-line therapy may have included a biologic agent (i.e. bevacizumab)
    • Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy
    • Patients must have clinically evident recurrent disease for the purpose of this study
    • Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be more than or equal to 20 mm when measured by conventional techniques, MRI or CT, or more than or equal to 10 mm when measured by spiral CT
    • Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1
    • Platelets greater than or equal to 100,000/mm^3 (CTCAE grade 0-1)
    • Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1
    • Total bilirubin =< 1.5 ULN (CTCAE grade 1)
    • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal in the absence of liver metastasis; SGOT/AST < 5.0 times ULN in the presence of liver metastasis
    • Alkaline phosphatase =< 2.5 times the upper limit of normal in the absence of liver metastasis; alkaline phosphatase < 5.0 times ULN in the presence of liver metastasis
    • This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL
    • This eligibility criterion does not apply to patients enrolled after August 28, 2011; patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization; patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking
    • Patients must have met the pre-entry requirements specified
    • Patients must have signed an approved informed consent and authorization permitting release of personal health information
    • Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

    Exclusion Criteria:

    • Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
    • Patients receiving concurrent immunotherapy, or radiotherapy
    • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
    • Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded
    • Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed
    • Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation
    • Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian tube, and primary peritoneal) are excluded
    • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
    • Patients with uncontrolled infection
    • Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
    • Patients with >= grade 2 peripheral neuropathy
    • Patients with a history of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds; patients with allergic (hypersensitivity) reactions to these chemotherapeutic agents are NOT excluded IF they were successfully retreated following a desensitization program or protocol
    • This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
    • Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant or patients who are nursing are not eligible for this trial; bevacizumab should not be administered to nursing women
    • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
    • This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
    • This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with a history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or a history of stroke within 5 years of the first date of treatment on this study
    • This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with clinically significant cardiovascular disease; this includes:
    • Patients with significant cardiac conduction abnormalities, i.e. PR interval > 0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block
    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
    • Myocardial infarction, cardiac arrhythmia or unstable angina < 6 months prior to registration
    • New York Heart Association (NYHA) grade II or greater congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Grade II or greater peripheral vascular disease (exception: episodes of ischemia < 24 hours [hrs] in duration, that are managed non-surgically and without permanent deficit)
    • History of cerebrovascular attack (CVA) within six months
    • This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
    • Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with bevacizumab on cycle #2
    • Patients undergoing pre-treatment surgery for purposes other than cytoreduction may also participate provided they meet eligibility; patients randomized to arms containing bevacizumab must wait a minimum of 28 days since that procedure to begin protocol treatment; patients who undergo an uncomplicated port placement must wait a minimum of 7 days to begin protocol treatment

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

    Protocol: CALGB-30610



    • Histologically or cytologically documented small cell lung cancer (SCLC)
    • Limited-stage disease
    • Disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
    • The following patients are not eligible:
    • Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes
    • Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not
    • Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray
    • Measurable disease, defined as at least one unidimensionally measurable lesion = 2 cm by conventional techniques OR = 1 cm by spiral CT scan


    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • Granulocytes = 1,500/µl
    • Platelet count = 100,000/µl
    • Total bilirubin = 1.5 times upper limit of normal (ULN)
    • AST = 2.0 times ULN
    • Serum creatinine = 1.5 times ULN OR creatinine clearance = 70 mL/min
    • Not pregnant or nursing
    • Negative pregnancy test
    • Fertile patients must use effective contraception


    • Patients may have received one and only one course of chemotherapy prior to enrolling on CALGB 30610, which must have included cisplatin and etoposide
    • If a patient has had one course of cisplatin/etoposide prior to registration, the patient must have had all of the prior-to-registration tests prior to starting their first course of chemotherapy
    • Registration to CALGB-30610 must take place within 14-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB-30610
    • No prior radiotherapy or chemotherapy (except for the chemotherapy described above) for SCLC
    • No prior mediastinal or thoracic radiotherapy
    • No prior complete surgical resection of SCLC
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  • open for enrollment

    MRI in Diagnosing Solid Tumors of the Eye and Orbit

    Protocol: OSU-0361


    Inclusion Criteria:

    • The patient has an orbital mass which needs further diagnostic evaluation before treatment or for monitoring
    • Able to give informed consent
    • Return for follow-up visits

    Exclusion Criteria:

    • Patients with a lesion < 2 mm
    • The patient should not participate in this study is any of the following applies to the patient: the patients has a pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, implanted electronic infusion pumps or any other condition that would interfere with the MRI, the patient has a stent somewhere in the body, the patient has a history of allergic reaction to any metals, contrast agents, x-ray dyes, the patient has claustrophobia
    • Patients cannot be pregnant and prisoners will not be considered for the study
    • Exposure to gadolinium-based contrast agents increases the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or severe renal dysfunction; therefore, patients with the following conditions are excluded from the study:
    • Acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m^2)
    • Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
    • In order to identify subjects at risk for the development of NSF, the American College of Radiology ( recommends obtaining a medical history and a glomerular filtration rate (GFR) assessment within six weeks of MR imaging in the following patients:
    • Renal disease (including solitary kidney, renal transplant, renal tumor)
    • Age > 60
    • History of hypertension
    • History of diabetes
    • History of severe hepatic disease/liver transplant/pending liver transplant
    • All subjects providing written informed consent will complete the subject history and screening form prior to MR imaging; the form will be reviewed to determine whether the subject is at risk as defined above and the availability of an estimated glomerular filtration rate (eGFR) within six weeks of anticipated MR imaging; an eGFR result greater than six weeks prior to the MRI imaging date will be repeated and evaluated for renal function; subjects with an eGFR of < 30 mL/min/1.73 m^2 will be excluded from the study

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    Ohio Patient Navigator Research Program

    Protocol: OSU-06100


    Inclusion Criteria: - Over age 18 years - Be a regular patient of the primary care practice - Be able to give informed consent - Have had either an abnormal screening test, an abnormal diagnostic test, or an abnormal clinical finding leading to diagnostic testing for cervical, breast, or colorectal cancer, or a diagnosis of cervical, breast, or colorectal cancer - Speak and understand English, or Spanish. For those participants who do not speak and understand English they will only be enrolled/consented into the program if translation services are available. Exclusion Criteria: - Cognitively impaired - Prior history of cancer (except for nonmelanoma of the skin) - Living in a nursing home - Prior navigation

    Principal Investigator: Electra D Paskett, PhD

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  • open for enrollment

    Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

    Protocol: CALGB-90203


    1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma.

    Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.

    All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.

    2. Clinically localized disease - Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:

    • EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes > 1.5 cm. If one or more pelvic lymph node(s) measures > 1.5 cm, a negative biopsy is required. If more than one lymph node is > 1.5 cm, the largest or most accessible node should be biopsied.


    • Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease.

    3. Determination of high-risk status: Patients must have either:

    • A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of < 60%.


    • Prostate biopsy Gleason sum = 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum = 8 only.)

    4. Prior treatment - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.

    Patients may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study.

    5. Appropriate surgical candidates - Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by a urologist. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications.

    6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy.

    7. ECOG performance status: 0-2

    8. Age: = 18 years of age

    9. Required Initial Laboratory Values:

    • ANC = 1500/µL
    • Platelet count = 150,000/µL
    • Creatinine = 2.0 mg/dL
    • Pre-registration serum PSA level = 100 ng/mL
    • Bilirubin = 1.5XULN (2.5XULN in patients with Gilbert's disease)
    • AST/ALT =1.5XULN
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