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

    Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Protocol: GOG-0225

    Eligibility:

    Inclusion Criteria:

    • Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
    • 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.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma
    • Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy or biological therapy
    • Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)
    • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
    • Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen
    • Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
    • Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization (previous 12 months)
    • Patients must complete all pre-entry assessments
    • Patients must have signed an approved informed consent and authorization permitting release of personal health information
    • Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC

    Exclusion Criteria:

    • Patients with GOG performance grade of 3 or 4
    • Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus
    • Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
    • Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
    • Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago
    • Patients with a life expectancy of less than one year
    • Patients with Body Mass Index (BMI) < 20 kg/m^2
    • Vegan vegetarians
    • Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue
    • Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months
    • Patients who have had surgery for weight loss

    Principal Investigator: David M O'Malley, MD

    Learn More
  • open for enrollment

    Ruxolitinib Prior to Transplant in Patients With Myelofibrosis

    Protocol: OSU-13112

    Eligibility:

    Inclusion Criteria:

    • Documented diagnosis of primary myelofibrosis according to WHO criteria or post PV myelofibrosis or post ET myelofibrosis as per IWG-MRT criteria
    • Age 18-70 years
    • Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) criteria OR Intermediate-1 risk disease with one of the following additional unfavorable features known to impact the survival adversely

    1. Red cell transfusion dependency

    2. Unfavorable Karyotype

    3. Platelet count <100 x 109/l

    • Blasts in the PB and BM =10% prior to study enrollment
    • Availability of a suitable matched related (6/6 or 5/6) or unrelated donor (10/10 or 9/10 antigen or allele matched).
    • Able to give informed written consent
    • ECOG Performance status of 0-2.
    • Life expectancy >3 months
    • Off all MF-directed therapy including investigational agents for at least 2 weeks prior to study enrollment and recovered from all toxicities*
    • Adequate organ function
    • Adequate renal function - creatinine <1.5 x IULN
    • Adequate hepatic function - AST/ALT <2.5 x IULN, Total Bilirubin <1.5 x IULN
    • Adequate hematopoietic function - Platelet =50 x 109/l and ANC =1.0 x 109/l
    • LVEF >40% (MUGA or echocardiogram) Normal per Institutional standard
    • Adequate pulmonary function with DLCO >50%
    • A patient who has been on stable dose of Ruxolitinib and has received ruxolitinib =6 months prior to the study entry will be considered potentially eligible for the study with the caveat that there is no evidence of loss of response (>5cm increase in spleen size from the nadir).

    Exclusion Criteria:

    • Any previous JAK2 inhibitor treatment prior to study enrollment, with the exception of Ruxolitinib
    • Hypersensitivity to JAK inhibitor
    • Clinical or laboratory evidence of cirrhosis
    • Prior allogeneic transplant for any hematopoietic disorder
    • >20% blast in the PB or BM prior to HCT or had leukemic transformation (>20% blasts in PB or BM any time prior to HCT)
    • Syngeneic donor
    • Cord Blood transplant
    • Active uncontrolled infection
    • H/o another malignancy within 5-years of date of HCT except h/o basal cell or squamous cell carcinoma of skin or PV or ET
    • Known HIV positive
    • Pregnancy at the time of BMT
    • Any other concurrent illness which in investigator's opinion puts the patient at excessive risk of treatment related toxicities
    • Unable to give informed consent
    • Active infection with hepatitis A,B or C virus
    • Subjects who require therapy with a strong CYP3A4 inhibitor prior to enrollment to this study
    Learn More
  • open for enrollment

    Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

    Protocol: ALLIANCE-A041202

    Eligibility:

    Inclusion Criteria:

    • Patients must be diagnosed with CLL in accordance with International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria that includes all of the following:
    • >= 5 x 10^9 B lymphocytes (5000/uL) in the peripheral blood
    • On morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes
    • CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of cluster of differentiation (CD)19 and CD20, as well as the T-cell antigen CD5; patients with bright surface immunoglobulin expression or lack of CD23 expression in > 10% of cells must lack t(11;14) translocation by interphase cytogenetics
    • Patients must be intermediate or high-risk Rai stage CLL
    • Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus enlarged lymph nodes at any site, with or without hepatomegaly or splenomegaly
    • High risk (formerly Rai stage III/IV) is defined by fulfilling criteria for intermediate risk disease plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia
    • Patients must meet criteria for treatment as defined by IWCLL 2008 guidelines which includes at least one of the following criteria:
    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
    • Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
    • Massive nodes (>= 10 cm) or progressive or symptomatic lymphadenopathy
    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
    • Constitutional symptoms, which include any of the following:
    • Unintentional weight loss of 10% or more within 6 months
    • Significant fatigue
    • Fevers > 100.5 degrees F for 2 weeks or more without evidence of infection
    • Night sweats > 1 month without evidence of infection
    • Prior teatment
    • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
    • Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment; palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of hepatitis B DNA are not eligible for this study; patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
    • Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
    • Patients must not be receiving active systemic anticoagulation with heparin or warfarin; patients must be off warfarin therapy for at least 30 days prior to enrollment
    • Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible
    • Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible
    • Patients with human immunodeficiency virus (HIV) are eligible if their CD4 count is >= 350 cells/mm^3 and if they are not taking prohibited cytochrome (CYP)-interacting medications
    • Patients must not have any history of Richter's transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%)
    • Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
    • Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
    • Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer
    • Patients must not have a known allergy to mannitol
    • Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions)
    • Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician
    • Absolute neutrophil count (ANC) >= 1,000/uL unless due to bone marrow involvement
    • Aspartate aminotransferase (AST) or alanine aminotransferase (AST) =< 2.5 x upper limits of normal except if due to disease infiltration of the liver
    • Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert's disease)
    • Creatinine clearance >= 40 mL/min
    • To be calculated by modified Cockcroft-Gault formula
    • Platelet count (untransfused) >= 30,000/uL

    Principal Investigator: Jennifer A Woyach, MD

    Learn More
  • open for enrollment

    A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

    Protocol: OSU-13093

    Eligibility:

    Inclusion Criteria:

    • Adult patient, >/= 18 years of age
    • HER2-positive breast cancer
    • Histologically confirmed invasive breast carcinoma
    • Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
    • Completion of preoperative systemic treatment consisting of at least 6 cycles with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
    • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
    • Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
    • An interval of no more than 12 weeks between the date of surgery and the date of randomization
    • Known hormone-receptor status
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    • Adequate hematologic, renal and liver function
    • Left ventricular ejection fraction (LVEF) >/= 50% at screening and no decrease in LVEF by more than 15% absolute points from pre-chemotherapy
    • Women of childbearing potential and men with partners of childbearing potential must be willing to use effective contraception as defined by protocol for the duration of study treatment and for at least 6 months after the last dose of study treatment
    • Documentation of hepatitis B virus and hepatitis C virus serology is required

    Exclusion Criteria:

    • Stage IV (metastatic) breast cancer
    • History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
    • Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
    • Progressive disease during preoperative therapy
    • Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
    • History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
    • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
    • Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
    • History of exposure to the following cumulative doses of anthracyclines:

    Doxorubicin > 240 mg/m2 Epirubicin > 480 mg/m2 For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2

    • Cardiopulmonary dysfunction as defined by protocol
    • Prior treatment with trastuzumab emtansine
    • Current severe, uncontrolled systemic disease
    • Pregnant or lactating women
    • Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
    • Concurrent serious uncontrolled infections or known infection with HIV
    • History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins

    Principal Investigator: William B Farrar, MD

    Learn More
  • open for enrollment

    Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Vulva

    Protocol: GOG-0279

    Eligibility:

    Inclusion Criteria:

    • Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva
    • Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy
    • Absolute neutrophil count (ANC) >= 1,500/mcl
    • Platelets >= 100,000/mcl
    • Creatinine =< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min
    • Bilirubin =< 1.5 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
    • Alkaline phosphatase =< 3 x ULN
    • Patients judged capable of tolerating a radical course of chemoradiation therapy
    • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
    • Patients must have signed an approved informed consent and authorization permitting release of personal health information
    • Patients with a GOG performance status of 0, 1, or 2

    Exclusion Criteria:

    • Patients with recurrent carcinoma of the vulva regardless of previous treatment
    • Patients who have received prior pelvic radiation or cytotoxic chemotherapy
    • Patients with vulvar melanomas or sarcomas
    • Patients with circumstances that will not permit completion of the study or the required follow-up
    • Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
    • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

    Principal Investigator: David M O'Malley, MD

    Learn More
  • open for enrollment

    Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

    Protocol: OSU-13098

    Eligibility:

    Inclusion Criteria:

    • A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
    • Patients must have borderline resectable or locally advanced unresectable pancreatic cancer with no metastatic spread as determined by a baseline diagnostic CT scan with intravenous contrast (or MRI). CT should be performed according to a defined pancreas protocol such as triphasic cross-sectional imaging with thin slices. Optimal multi-phase technique including a non-contrast phase plus arterial, pancreatic parenchymal and portal venous phase of contrast enhancement with thin cuts (3mm) throughout the abdomen is preferred. Studies must be evaluated by a radiologist and/or surgeon and deemed borderline resectable or locally advanced unresectable as defined per the NCCN Practice Guidelines in Oncology V2.2012, as:
    • Borderline resectable- Tumors considered borderline resectable are defined as follows:

    1. No distant metastases

    2. Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen, encasement of the SMV/portal vein but without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection and reconstruction

    3. Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery without extension to the celiac axis.

    4. Tumor abutment of the SMA not to exceed greater than 180 degrees of the circumference of the vessel wall.

    • Tumors considered to be unresectable due to local advancement include an absence of distant metastases as well as:

    1. Head: Greater than 180 degrees SMA encasement or any celiac abutment or unreconstructible SMV/portal occlusion or aortic invasion or encasement.

    2. Body: Greater than 180 degrees SMA or celiac encasement or unreconstructible SMV/portal occlusion or aortic invasion.

    3. Tail: SMA or celiac encasement greater than 180 degrees.

    4. Nodal status: Involvement of lymph nodes beyond the field of resection should be considered unresectable due to distant spread and therefore not eligible for this protocol.

    • Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.
    • Serum albumin = 2.0 gm/dL.
    • Expected survival = 6 months.
    • Adequate organ function including:

    1. Marrow: WBC =3000/mm^3 and platelets =100,000/mm^3.

    2. Hepatic: serum total bilirubin = 1.5 mg/dL, ALT (SGPT) and AST (SGOT) =3 x upper limit of normal (ULN) at time of enrollment. If a patient has elevated liver function tests at the time of initial presentation or develops them during work-up and they are the result of a mechanical obstruction of biliary drainage by tumor compression or invasion, a biliary drain may be placed as described in NCCN Practice Guidelines in Oncology V2.2012. If drainage allows for the liver function tests to come within inclusion criteria, the patient may be enrolled.

    3. Renal: serum creatinine (sCr) =2.0 x ULN, or creatinine clearance (Ccr) =30 mL/min.

    • Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
    • All subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product, and for one month after the last immunization.

    Exclusion Criteria:

    • Age <18-years-old.
    • Active metastases.
    • Other malignancy within five years, unless the probability of recurrence of the prior malignancy is <5% as determined by the Principal Investigator based on available information. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
    • History of organ transplant.
    • Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
    • Subjects taking chronic systemic corticosteroid therapy for any reason are not eligible. Subjects may receive steroids as prophylactic anti-emetics per the FOLFIRINOX or gemcitabine/nab-paclitaxel regimen. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require chronic systemic corticosteroids after beginning treatment, will be removed from study.
    • Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last six months.
    • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
    • Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible.
    • Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., active liver cirrhosis) or a serious illness in medical opinion of the clinical investigator.
    • Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.).
    • A known history of allergy or hypersensitivity to any of the study drugs or any of their excipients.
    • Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant. (For patients with child bearing potential, a ßHCG must be completed within 14 days of first treatment).
    • Known HIV positive.
    • Prior treatment with chemotherapy or radiation for pancreatic cancer or prior treatment with radiation for other diagnoses to expected pancreatic cancer treatment fields.
    • Current grade II or higher peripheral neuropathy.

    Principal Investigator: Tanios Bekaii-Saab, MD

    Learn More
  • open for enrollment

    A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma

    Protocol: OSU-13089

    Eligibility:

    Inclusion Criteria:

    • Male or female patients =18 years old.
    • Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.
    • The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
    • A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1.
    • Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
    • Patients must receive RT at the participating institution.
    • Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for =1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose.
    • Karnofsky performance status of =70.
    • Adequate hematologic, hepatic, and renal function (absolute neutrophil count =1.5x 109/L, Hgb >10 g/dL, platelet count =100 x 109/L, AST/ALT =2.5x ULN, creatinine =1.5x ULN).
    • Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.

    Exclusion Criteria:

    • Evidence of recurrent GBM or metastases detected outside of the cranial vault.
    • Investigational drug use within 28 days of the first dose of PLX3397 or concurrently.
    • Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.
    • Prior radiation or chemotherapy for glioblastoma or glioma.
    • Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields.
    • Prior allergic reaction to temozolomide.
    • History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage.
    • Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix.
    • Chronic active hepatitis B or C.
    • Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug.
    • Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
    • Women of child-bearing potential who are pregnant or breast feeding.
    • At Screening QTcF =450 msec for males and =470 msec for females.

    Principal Investigator: Vinay K Puduvalli, MD

    Learn More
  • open for enrollment

    Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer

    Protocol: RTOG-1010

    Eligibility:

    Inclusion Criteria:

    • Pathologically confirmed primary adenocarcinoma of the esophagus that involves the mid (up to 25 cm), distal, or esophagogastric junction; the cancer may involve the stomach up to 5 cm
    • Endoscopy with biopsy
    • PRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATION
    • Intent to submit tissue for central HER2 testing
    • Stage T1N1-2, T2-3N0-2, according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based on the following minimum diagnostic work-up:
    • Chest/abdominal/pelvic computed tomography (CT) or whole-body positron emission tomography (PET)/CT (NOTE: if CT is performed at this time point, whole-body PET/CT will be required prior to step 2 registration; PET/CT of skull base to mid-thigh is acceptable) (NOTE: if adenopathy is noted on CT or whole-body PET/CT scan, an endoscopic ultrasound is not required prior to STEP 2 registration as long as adequate tissue has been obtained for central HER2 testing)
    • Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be =< 2 cm
    • Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula
    • Zubrod performance status 0-2
    • Absolute neutrophil count (ANC) >= 1,500 cells/mm³
    • Platelets >=100,000 cells/mm³
    • Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
    • Creatinine =< 2 times upper limit of normal
    • Bilirubin =< 1.5 times upper limit of normal
    • Aspartate aminotransferase (AST) =< 3.0 times upper limit of normal
    • For women of childbearing potential, a negative serum or urine pregnancy test
    • Patients must sign a study-specific informed consent prior to study entry
    • CONDITIONS FOR PATIENT ELIGIBILITY PRIOR TO STEP 2 REGISTRATION (HER2-POSITIVE PATIENTS ONLY)
    • HER2 expressing adenocarcinoma of the esophagus centrally
    • Surgical consultation to confirm that patient will be able to undergo curative resection after completion of chemoradiation within 56 days prior to step 2 registration
    • Radiation oncology consultation to confirm that disease can be encompassed in a radiotherapy field within 56 days prior to step 2 registration
    • Consultation with a medical oncologist within 56 days prior to step 2 registration
    • Stage T1N1-2, T2-3N0-2, according to the AJCC 7th edition staging, based upon the following minimum diagnostic work-up:
    • History/physical examination, with documentation of the patient's weight, within 14 days prior to step 2 registration
    • Whole-body PET/CT scan within 56 days prior to step 2 registration (if only CT performed prior to step 1 registration)
    • Endoscopic ultrasound within 56 days prior to step 2 registration, unless the patient is found to have adenopathy per CT or whole-body PET/CT scan
    • Electrocardiogram (EKG) within 56 days prior to step 2 registration
    • Serum creatinine =< 2 x the upper limit or normal within 14 days prior to step 2 registration
    • Zubrod performance status 0-2 within 14 days prior to step 2 registration
    • For women of childbearing potential, a negative serum pregnancy test within 14 days prior to step 2 registration
    • Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by cardiac echocardiogram (echo) or multi gated acquisition (MUGA) scan within 56 days prior to step 2 registration
    • Women of childbearing potential and sexually active male participants must agree to practice adequate contraception while on study and for at least 60 days following the last dose of chemotherapy or trastuzumab

    Exclusion Criteria:

    • Patients with cervical esophageal carcinoma
    • Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm)
    • Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable
    • Prior radiation therapy for esophageal cancer or prior chest radiotherapy
    • Prior anthracycline or taxane
    • Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
    • Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are permissible)
    • Medical contraindications to esophagectomy
    • Prior therapy with any agent targeting the HER2 pathway or human epidermal growth factor receptor 1 (HER1) (epidermal growth factor receptor [EGFR]) pathway
    • Prior therapy with trastuzumab
    • Prior allergic reaction to the study drugs involved in this protocol or to a monoclonal antibody
    • Previous history of congestive heart failure
    • Severe, active comorbidity, defined as follows:
    • Unstable angina in 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
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immunocompromised patients
    • Pregnant or nursing women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

    Principal Investigator: Evan J Wuthrick, MD

    Learn More
  • open for enrollment

    Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

    Protocol: SWOG-S1007

    Eligibility:

    Inclusion Criteria:

    • Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status; estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ hybridization (ISH) or both; HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/CEP ration < 2.0 with an average copy number < 4.0 signals per cell by dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2 equivocal is not eligible
    • Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed
    • Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant; (NOTE: The Oncotype DX testing must be completed on the largest lesion)
    • Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants (NOTE: Oncotype DX testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score)
    • Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: The Oncotype DX testing should be completed on both tumors and the tumor with the highest recurrence score should be used)
    • Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND); patients must have at least one, but no more than three known positive lymph nodes (pN1a, pN1b or pN1c); patients with micrometastases as the only nodal involvement (pN1mi) are not eligible; patients with positive sentinel node are not required to undergo full axillary lymph node dissection; this is at the discretion of the treating physician; axillary node evaluation is to be performed per the standard of care at each institution
    • Patients must not have inflammatory breast cancer and must not have metastatic disease; patients with a prior diagnosis of ductal carcinoma in situ (DCIS) are eligible if they received mastectomy alone (no therapeutic radiation, intraoperative radiation, or endocrine therapy); radiation in the opposite breast is acceptable; partial breast irradiation (including brachytherapy) is not allowed
    • Patients must have had breast-conserving surgery with planned radiotherapy or total mastectomy (with or without planned post mastectomy radiation); patients must have clear margins (as per local institutional guidelines)
    • Registration of patients who have not yet undergone Oncotype DX screening must occur no later than 56 days after definitive surgery; (for all patients, Step 2 Registration must occur within 84 days after definitive surgery); if the Oncotype DX Breast Cancer Assay has not been performed, patients must be willing to submit tissue samples for testing to determine the Recurrence Score value; a representative block or unstained sections from the representative block are sent directly to Genomic Health for Oncotype DX Breast Cancer Assay which will be performed according to the standard commercial process
    • If the Oncotype DX Recurrence Score is already known and is 25 or less, the patient must be registered to Step 2 immediately following Step 1 registration; if the Oncotype DX Recurrence Score is already known and is greater than 25, the patient is ineligible
    • Patients must have a complete history and physical examination within 28 days prior to registration
    • Patients must have a performance status of 0-2 by Zubrod criteria
    • Patients must be able to receive taxane and/or anthracycline based chemotherapy
    • Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration
    • Patients must not require concurrent chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents
    • Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration
    • Patients must not be pregnant or nursing; women of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
    • No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
    • The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients who consented to QOL prior to 12/1/12 should continue to complete QOL forms per their expectation report; patients who are able to complete a questionnaire in English must be offered the opportunity to participate in the Quality of Life and Economic Substudy. (The Quality of Life and Economic Substudy is available to U.S. INSTITUTIONS ONLY); patients who are not able to complete a questionnaire in English are registered to S1007 without participating in the Quality of Life and Economic Substudy
    • Patients who consent to participate in the Quality of Life and Economic Substudy and who do not yet know the results of their Oncotype DX screening must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Enrollment between 14 days prior to and 7 days after Step 1 Registration
    • Patients who consent to participate in the Quality of Life and Economic Substudy and who do already know their Oncotype DX Recurrence Score (and it is 25 or less) will proceed to Step 2 Registration without completing the S1007 Health-Related Quality of Life Questionnaire Enrollment Form (but will complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form)
    • Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent Form
    • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
    • STEP 2 REGISTRATION
    • Recurrence score (RS) by Oncotype DX must be =< 25
    • Step 2 Registration must take place within 84 days after definitive surgery; patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to randomization
    • Patients randomized to either arm may also co-enroll in Phase III trials that compare local therapies, or compare systemic therapies (not including chemotherapy); patients randomized to chemotherapy may also co-enroll in Phase III trials that compare chemotherapies (including S1207)

    Principal Investigator: Maryam B Lustberg, MD, MPH

    Learn More
  • open for enrollment

    L-asparaginase Encapsulated in Red Blood Cells for Frontline Therapy of Patients With Phi-neg ALL Older Than 40 yo

    Protocol: OSU-13111

    Eligibility:

    Inclusion Criteria:

    • Man or woman aged 40 years and over
    • Diagnosis of acute lymphoblastic leukemia
    • No prior treatment. Emergency leukapheresis is permissible.
    • Patient capable to receive multi-agent ALL chemotherapy (WHO performance status 0-2)
    • Management throughout the full duration of protocol treatment at a medical facility having ready access to blood product support and adequately staffed to care for the severely neutropenic patient with multiple therapy-induced toxicities.
    • Signed Informed Consent Form

    Exclusion Criteria:

    • ALL t(9;22) or BCR-ABL positive or Burkitt-type ALL [positive for t(8;14), etc.]
    • Other serious medical illness other than that treated by this study which would limit survival to <2 years or psychiatric conditions which would prevent informed consent or compliance with treatment.
    • Presenting with a general or visceral contraindication to intensive treatment including:
    • uncontrolled or severe cardiovascular disease, including recent (<6 months) myocardial infarction or congestive heart failure,
    • pancreatic diseases,
    • history of coagulopathy or current coagulopathy, thrombosis and/or hemostasis disorders,
    • plasma creatinine concentration, 1.5 times greater than the upper limit of laboratory normal ranges (ULN), except if related to ALL,
    • total bilirubin 1.5 times greater than the ULN, except if related to ALL,
    • transaminases (AST or ALT) levels, 5 times greater than the ULN, except if related to ALL,
    • previous or concomitant malignancy other than curatively treated carcinoma in situ of cervix or basal cell carcinoma of the skin, or other cancer if the patient has been disease free for >5 years,
    • active uncontrolled bacterial, viral, or fungal infection or an active duodenal ulcer, until these conditions are corrected or controlled.
    • Prior treatment with L-asparaginase (irrespective of the form).
    • History of allergy to penicillin or related antibiotic
    • History of grade 3 blood transfusion incident according to US Biovigilance Network which refers to any transfusion followed by a major intervention (vasopressors, intubation, transfer to intensive care) to prevent death.
    • Presenting with rare and/or dangerous anti-erythrocyte antibodies, thus leading to the unavailability of phenotype compatible red blood cells.
    • Participation in a clinical study involving receipt of an investigational drug during the last 30 days.
    • Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
    • Patient receiving treatment likely to cause hemolysis or under phenytoin treatment.
    • Patient undergoing yellow fever vaccination.
    Learn More