Filter Your Search

  • ?
    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.
  • ?
    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

    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 70 days prior to registration:
    • A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast)
    • Or an 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 radiation planning and read by a radiologist 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: 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; 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); HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions
    • 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

    Learn More
  • open for enrollment

    Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases

    Protocol: OSU-13197

    Eligibility:

    Inclusion Criteria:

    • Histologically confirmed cancer with measurable or evaluable brain metastases by computed tomography (CT) or magnetic resonance imaging (MRI); MRI is preferred, but a CT scan is acceptable for patients that are unable to have an MRI
    • Presence of a KRAS gene mutation (at codon 12,13, 61) , a BRAF gene mutation (V600E or V600K), an NRAS mutation (at codon 12, 13, 61), or HRAS mutation (at codon 12, 13, 61) (for Cohort A only); this testing should be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified pathology laboratory; a copy of the pathology report documenting the presence of a KRAS, BRAF, HRAS, or NRAS mutation is required for enrollment on Cohort A
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 -1
    • All prior treatment- related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment
    • Absolute neutrophil count >= 1.5 × 10^9/L
    • Hemoglobin >= 9 g/dL
    • Platelets >= 100 x10^9/L
    • Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation
    • Albumin >= 2.5 g/dL
    • Total bilirubin =< 1.5 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 × ULN
    • Creatinine =< 1.5 ULN or calculated creatinine clearance >= 50 mL/min or 24-hour urine creatinine clearance >= 50 mL/min; calculated by the Cockcroft-Gault formula
    • Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) by echocardiogram (ECHO) or multigated acquisition scan (MUGA); same method as used at baseline must be use throughout the study, ECHO is the preferred method
    • Life expectancy of at least 3 months in the opinion of investigator
    • 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
    • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
    • Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment, and counseled on contraception/abstinence while receiving the study treatment; urine or serum human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment; 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; women of child-bearing potential must have a negative serum or urine pregnancy test within 14 days prior to randomization; 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 administration)

    Exclusion Criteria:

    • Prior radiation therapy to the whole brain (prior stereotactic radiosurgery or fractionated stereotactic radiation therapy to focal areas is allowed)
    • Prior treatment with a selective inhibitor of v-RAF-1 murine leukemia viral oncogene homolog (RAF) or mitogen-activated protein kinase kinase (MEK) (trametinib, dabrafenib, vemurafenib, etc.)
    • Evidence of leptomeningeal metastases
    • Urgent need of treatment to prevent acute neurologic deterioration
    • Radiosensitive primary tumor such as small cell lung cancer, germ cell tumors, lymphoma, leukemia, or multiple myeloma
    • History of another malignancy that makes determination of the source of the brain metastases uncertain
    • History of interstitial lung disease or pneumonitis
    • Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 14 days prior to enrollment and/or daily or weekly chemotherapy with the potential for delayed toxicity within 14 days prior to enrollment
    • Use of other anti-cancer therapies within five half-lives from the previous dose of the prior anti-cancer therapy preceding the first dose of trametinib and during the study
    • Symptomatic or untreated spinal cord compression
    • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO)
    • Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:
    • Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)
    • Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis
    • Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
    • In vitro studies suggest that the metabolism of trametinib is mediated predominantly by non-cytochrome (CYP)-mediated processes and possibly by cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); therefore, drugs that potently inhibit or induce CYP3A4 should be administered with caution, as they may alter exposure to trametinib; below are a few examples of the agents:
    • Drugs that may increase exposure of trametinib (CYP3A4 inhibitors):
    • Antivirals: Amprenavir, atazanavir, fosamprevanir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir
    • Antibiotics: Clarithromycin, erythromycin, telithromycin, troleandomycin
    • Antifungals: Fluconazole, itraconazole, ketoconazole, voriconazole
    • Antidepressants: Nefazodone
    • Calcium channel blockers: Mibefradil, diltiazem, verapamil
    • Miscellaneous: Aprepitant
    • Drugs that may decrease exposure of trametinib (CYP3A4 inducers)
    • Antivirals: Efavirenz, nevirapine
    • Antibiotic: Rifampin
    • Anticonvulsants: Carbamazepine, phenobarbital, phenytoin
    • Trametinib may be an inhibitor of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) in vivo; caution should be exercised when dosing trametinib concurrently with medications with narrow therapeutic windows that are substrates of CYP2C8; below are a few examples of the agents
    • Drug metabolism potentially affected by trametinib resulting in increased exposure of these substrates
    • 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA)-reductase inhibitors: Cerivastatin
    • Thiazolidinediones: Rosiglitazone, pioglitazone
    • Miscellaneous: Chloroquine, zopiclone, repaglinide
    • As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
    • History or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED):
    • History of RVO or RPED, or predisposing factors to RVO or RPED (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
    • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or RPED such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mm Hg
    • History or evidence of cardiovascular risk including any of the following:
    • LVEF< LLN.
    • A QT interval corrected for heart rate using the Bazett's formula QTcB >= 480 msec
    • History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible)
    • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization
    • History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system
    • Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy
    • Patients with intra-cardiac defibrillators
    • Known cardiac metastases
    • Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection, which will be allowed); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications
    • 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
    • Pregnancy or breastfeeding (women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable); radiation therapy is also contraindicated in pregnancy
    • Unable to reliably be immobilized for safe administration of whole brain radiation therapy
    Learn More
  • open for enrollment

    COMPARATIVE ASSESSMENT OF FOOD FREQUENCY QUESTIONNAIRES STUDY

    Protocol: OSU-14222

    Principal Investigator: Steven K Clinton, MD, PhD

    Learn More
  • open for enrollment

    Compassionate use of ABT 888 for a patient with metastatic breast cancer

    Protocol: OSU-14241

    Principal Investigator: Maryam B Lustberg, MD, MPH

    Learn More
  • open for enrollment

    Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

    Protocol: OSU-09138

    Eligibility:

    Inclusion Criteria:

    • Must have histologically confirmed metastatic solid tumor; the malignancy should be considered incurable using standard treatment
    • Patients are not required to have HER-2 over-expression to be on this study
    • If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted
    • If the patient has not had HER-2 expression measured prior to enrollment on this study tumor tissue blocks and/or freshly isolated tissue must be available for determination of HER-2 expression
    • Patients are not required to have epidermal growth factor receptor (EGFR) over-expression to be on this study
    • If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted
    • If the patient has not had EGFR expression measured prior to enrollment on this study tumor tissue blocks and/or freshly isolated tissue must be available for determination of EGFR expression
    • Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible
    • Patients must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    • White blood cells > 3500/mm^3
    • Platelet count > 100,000/mm^3
    • Serum bilirubin < 1.5 mg %, regardless of whether patients have liver involvement secondary to tumor
    • Alanine aminotransferase (ALT) must be < 2 times upper limit of normal
    • Creatinine < 1.5 mg/dL or calculated creatinine clearance > 60 mL/min
    • Patients will be tested for reactivity to a panel of four common microbial skin test antigens: candida, trichophyton, intermediate strength purified protein derivative (PPD), and tetanus toxoid; determination of patient eligibility for this trial will proceed independently of these skin test results; patients who have previously been tested for these antigens but were excluded from participation in the trial due to non-reactivity may be considered as eligible provided that all other eligibility criteria are met
    • Patients must be at least 4 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy; patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half life of the agent); patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2
    • Women of child-bearing potential must not be pregnant and must have a negative pregnancy test; men and women must agree to practice effective contraception while on this study
    • Patients must obtain a base line Echocardiogram or multi gated acquisition scan (MUGA) and require the left ventricular ejection fraction to be within normal limits (or 50% or higher)
    • Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

    Exclusion Criteria:

    • Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive
    • Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection; if patient develops an infection requiring antibiotic treatment while on the treatment portion of the study patients will be treated for the active infection with antibiotics and will resume vaccine treatment when the infection is healed
    • Patients with known active human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection
    • Patients with serious cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases
    • Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible
    • Splenectomized patients
    • Autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, or a vasculitic syndrome
    • Patients who have developed anaphylactic responses to other vaccines
    • History of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention

    Principal Investigator: Tanios Bekaii-Saab, MD

    Learn More
  • open for enrollment

    Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy

    Protocol: RTOG-0724

    Eligibility:

    DISEASE CHARACTERISTICS:

    • Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
    • Positive pelvic nodes
    • Positive parametrium
    • Positive para-aortic nodes that have been completely resected and are PET/CT scan-negative
    • PET only required if positive para-aortic nodes during surgery
    • Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node metastasis (TNM) staging of T1-T2, N1, M0)
    • Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
    • Para-aortic and pelvic node sampling required
    • If the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required
    • A negative pre- or post-operative PET scan or PET-CT scan of the para-aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection
    • No gross residual disease
    • No neuroendocrine histology
    • No distant metastases

    PATIENT CHARACTERISTICS:

    • Zubrod performance status 0-1
    • Absolute neutrophil count (ANC) = 1,800/mm³
    • Platelets = 100,000/mm³
    • White blood cell count (WBC) = 4,000/mm³
    • Hemoglobin = 10.0 g/dL (transfusion or other intervention allowed)
    • Serum creatinine = 1.5 mg/dL
    • Bilirubin = 1.5 times upper limit of normal
    • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) normal
    • Alkaline phosphatase normal
    • Known HIV positivity allowed provided cluster of differentiation 4 (CD4) count is = 350/mm³ within the past 14 days
    • No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
    • No severe, active co-morbidity, including any of the following:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
    • Coagulation defects
    • No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

    PRIOR CONCURRENT THERAPY:

    • See Disease Characteristics
    • No prior systemic chemotherapy for the current cervical cancer
    • Prior chemotherapy for a different cancer is allowed
    • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
    Learn More
  • open for enrollment

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

    Protocol: NRG-HN001

    Eligibility:

    Inclusion Criteria:

    • Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th ed.) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:
    • History/physical examination by a Medical Oncologist and/or Radiation Oncologist, which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration
    • Evaluation of tumor extent with magnetic resonance imaging (MRI) of the nasopharynx and neck within 28 days prior to registration; if MRI is medically contraindicated, obtain computed tomography (CT) scan with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement); Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist
    • To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:
    • A CT scan with contrast of the chest, abdomen, and pelvis or a total body positron emission tomography (PET)/CT scan
    • A bone scan, if a PET/CT scan is not performed
    • Zubrod performance status 0-1 within 21 days prior to registration
    • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
    • Platelets >= 100,000 cells/mm^3
    • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN
    • Alkaline phosphatase =< 1.5 x institutional ULN
    • Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula
    • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
    • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
    • Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay

    Exclusion Criteria:

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

    EFFICACY OF TRAMETINIB IN RECURRENT OR PROGRESSIVE LOW-GRADE SEROUS OVARIAN OR PERITONEAL CA

    Protocol: GOG-0281

    Principal Investigator: David M O'Malley, MD

    Learn More
  • open for enrollment

    Impact of Anti-androgen Treatment on Cardiac Function

    Protocol: OSU-14186

    Principal Investigator: Steven K Clinton, MD, PhD

    Learn More