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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

    Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

    Protocol: ECOG-E1411

    Eligibility:

    DISEASE CHARACTERISTICS:

    • Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH)
    • Patients must have at least one objective measurable disease parameter
    • Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
    • Measurable disease in the liver is required if the liver is the only site of lymphoma
    • Patient must have no CNS involvement

    PATIENT CHARACTERISTICS:

    • ECOG performance status 0-2
    • ANC = 1,500/mcL (1.5 x 10^9/L)*
    • Platelets = 100,000/mcL (100 x 10^9/L)* NOTE: *Unless due to marrow involvement.
    • AST/ALT = 2 times upper limit of normal (ULN)
    • Bilirubin = 2 times ULN
    • Calculated creatinine clearance by Cockroft-Gault formula = 30 mL/min
    • Women (sexually mature female) must not be pregnant or breast-feeding
    • Negative pregnancy test
    • Women of childbearing potential and sexually active males use an accepted and effective method of contraception
    • Men must agree to use a latex condom during sexual contact with a female of child-bearing potential, even if they have had a successful vasectomy
    • All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
    • No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically or radiation-cured malignancy continuously disease free for = 5 years so as not to interfere with interpretation of radiographic response
    • Patient agrees that if randomized to Arms C or D, and proceed onto Arms G or H, they must register into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
    • Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have DVT prophylaxis
    • Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have therapeutic doses of low-molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0
    • Patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis
    • Patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment
    • Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment
    • Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment
    • HIV-positive patients are not excluded but, to enroll, must meet all of the below criteria:
    • HIV is sensitive to antiretroviral therapy
    • Must be willing to take effective antiretroviral therapy, if indicated
    • No history of CD4 prior to or at the time of lymphoma diagnosis < 300 cells/mm³
    • No history of AIDS-defining conditions
    • If on antiretroviral therapy, must not be taking zidovudine or stavudine
    • Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm³, whichever occurs later
    • Patients must not have grade 2 or greater peripheral neuropathy
    • Patients must not have NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
    • Patients must not have hypersensitivity to bortezomib, boron, or mannitol
    • Patients must not have a serious medical or psychiatric illness likely to interfere with study participation

    PRIOR CONCURRENT THERAPY:

    • No prior therapy for MCL, except < 1 week of steroid therapy for symptom control
    • HIV-positive patients are not excluded, but to enroll, must meet all of the below criteria:
    • Must be willing to take effective antiretroviral therapy if indicated
    • If on antiretroviral therapy, must not be taking zidovudine or stavudine
    • Patients must not be participating in any other clinical trial or taking any other experimental medications within 14 days prior to registration

    Principal Investigator: Kristie A Blum, MD, Affiliate

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  • open for enrollment

    Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer

    Protocol: OSU-11182

    Eligibility:

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma of colorectal origin that is metastatic or locally advanced and unresectable
    • Measurable disease, as defined by RECIST 1.1 criteria: one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with spiral computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm) malignant lymph nodes will be considered measurable if they are >= 15 mm in short axis
    • Must not have received any prior systemic therapy for metastatic or locally advanced CRC; prior VEGF inhibitors are not allowed
    • Prior adjuvant therapy for CRC including fluoropyrimidines either alone or in combination with oxaliplatin is allowed, provided that all therapy was completed >= 12 months from cancer recurrence, therapy duration was =< 6 months, and all prior toxicities have completely resolved (residual grade 1 neuropathy is allowed)
    • Life expectancy >= 12 weeks
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Hemoglobin >= 9 g/dL (blood transfusion permitted to attain this value)
    • Absolute neutrophil count >= 1,500/uL
    • Platelets >= 100,000/uL
    • Total bilirubin =< 2 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (may be =< 5x ULN if increase is due to metastatic disease)
    • Creatinine =< 1.5 x institutional ULN or creatinine clearance >= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional U
    • Urine protein:creatinine ratio (UPCR) < 1 or < 500 mg protein/24 hr
    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • May not be receiving any other investigational agents
    • Patients who have received any prior locoregional therapy for metastatic disease (e.g. radiofrequency/microwave ablation, Yttrium-90 radioembolization, transarterial chemoembolization, or surgical resection) are excluded
    • Patients with known or suspected brain metastases, carcinomatous meningitis, uncontrolled seizure disorder, active intracranial bleeding or active neurologic disorder are excluded
    • Patients with an active second primary malignancy or history of malignancy within the 5 years of enrollment are excluded, with the exception of non-melanoma skin cancers and cervical cancer which has been treated with curative therapy
    • Grade >= 2 sensory neuropathy at the time of enrollment
    • Major surgery within 4 weeks of study start date; the surgical incision should be fully healed prior to initiation of aflibercept
    • Female or male patients of reproductive capacity unwilling to use methods appropriate to prevent pregnancy are excluded; effective contraception is required for at least 3 months following the last administration of aflibercept
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension (blood pressure [BP] must be well controlled < 160/90), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or any condition that the principal investigator (PI) feels would make the patient ineligible
    • Positive pregnancy screening test with a minimum sensitivity of 25 IU/L of human chorionic gonadotropin (hCG) within 72 hours of registration; breastfeeding women are also excluded
    • History of pulmonary embolus within 3 months or deep venous thrombosis (DVT) within 4 weeks of enrollment; patients on anticoagulation must be on a stable dose of warfarin with a therapeutic-range international normalized ratio (INR) or on a stable dose of low molecular weight heparin
    • Active congestive heart failure (New York Heart Association [NYHA] class II-IV)
    • History of an arterial thrombotic vascular event including cerebrovascular accident (CVA), myocardial infarction (MI), unstable angina, coronary or peripheral arterial bypass graft, or transient ischemic attack (TIA) within 6 months
    • Serious or non-healing wound, ulcer or bone fracture at the time of medication administration
    • History of treatment-resistant peptic ulcer disease, erosive esophagitis, gastritis, or diverticulitis within 3 months
    • History of gastrointestinal (GI) perforation within 5 years; current or prior intestinal fistulas are also excluded
    • Known chronic infectious disease including human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
    • History of major hemorrhage including gastrointestinal bleeding (grade 2-4), pulmonary hemorrhage, or clinically significant hemoptysis (> 1 tsp in 24 hours) within the last 5 years; patients with underling conditions that predispose to bleeding, such as bleeding diathesis, known esophageal varices, or tumor involving major vessels, are also excluded
    • Inability to understand or comply with study protocol
    • Known hypersensitivity to Chinese hamster ovary cell products or to recombinant human or murine antibodies, or any of the treatments in this protocol

    Principal Investigator: Richard M Goldberg, MD

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  • open for enrollment

    Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

    Protocol: OSU-12106

    Eligibility:

    Inclusion Criteria:

    • Must have histologically proven relapsed or refractory B-cell NHL of the following World Health Organization (WHO) classification subtypes: follicular lymphoma (FL), mantle cell lymphoma (MCL), lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL), Burkitt's lymphoma (BL), and B-cell lymphoma with features unclassifiable between Burkitt's and large cell lymphoma; alternatively, patients with histologically proven, newly diagnosed transformed non-Hodgkin's lymphoma (tNHL) are eligible
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • At least one prior therapy; patients with newly diagnosed tNHL are eligible and do not need to have received prior therapy for the transformed lymphoma or prior indolent NHL; prior autologous stem cell transplant is allowed
    • Serum creatinine =< 2.0 mg/dL
    • Total bilirubin within normal limits
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 1.5 x upper limit of normal
    • Absolute neutrophil count (ANC) >= 1000/µL
    • Platelet count >= 75,000/µL
    • Recovery to =< grade 1 toxicities associated with prior therapy
    • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
    • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
    • Male subject agrees to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237
    • Must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration

    Exclusion Criteria:

    • Pregnant or breast-feeding women and women of childbearing age who are unwilling to use adequate contraception
    • Patients with a history of central nervous system involvement by lymphoma
    • Patients with known human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active or carriers) are not eligible; this includes all patients with a positive hepatitis C antibody, hepatitis B surface antigen, or hepatitis B core antibody; previously vaccinated patients with positive hepatitis B surface antibody are eligible
    • May not have received prior therapy with an Aurora kinase inhibitor
    • Patients eligible for and willing to undergo autologous stem cell transplant with curative intent at the time of enrollment are not eligible; patients refractory to at least 2 prior regimens may enroll and proceed to curative autologous transplant if they respond
    • Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is equivalent to greater than 10 mg prednisone
    • Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%
    • Prior allogeneic bone marrow or organ transplantation
    • If applicable, patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
    • Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen
    • Patients who are on daily proton pump inhibitor therapy must be able to discontinue use or only require use of antacid or hydrogen (H2) antagonist intermittently; patients who require daily administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes are not eligible; intermittent uses of antacids or H2 antagonists are allowed
    • Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection
    • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities (except asymptomatic patients with a pacemaker with electrocardiogram (ECG) changes reflecting conduction abnormalities secondary to the pacemaker); prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant
    • Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
    • Patient has received other investigational drugs with 14 days before enrollment
    • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
    • Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study
    • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
    • Treatment with clinically significant enzyme inducers, such as the enzyme- inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study
    • Patients with a corrected QT interval (QTc) at baseline of > 450 milliseconds or other factors that increase the risk of QT prolongation or arrhythmic events (i.e., heart failure, hypokalemia with potassium < 3.5 despite supplementation, family history of long QT syndrome) should be excluded
    • Patients who require use of a concomitant medication that can prolong the QT interval and who are unable to discontinue use of this medication during the study period are excluded

    Principal Investigator: Kristie A Blum, MD, Affiliate

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  • open for enrollment

    The PUMA Trial is a Trial of a Single ProHema Modulated-CB Unit as Part of a Double CB Transplant in Patients With Hematologic Malignancies.

    Protocol: OSU-12091

    Eligibility:

    Inclusion Criteria:

    1. Subjects with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate. Eligible diseases and stages include:

    • Acute lymphoblastic leukemia (including T lymphoblastic leukemia) in complete remission.
    • Remission is defined as < 5% blasts with no morphological characteristics of acute leukemia in a bone marrow with > 20% cellularity.
    • Acute myelogenous leukemia in high risk first CR or second or subsequent CR.
    • High risk first CR is defined by but is not limited to at least one of the following factors: greater than 1 cycle of induction chemotherapy to achieve CR, prior myelodysplastic syndrome (MDS), presence of Flt3 abnormalities, FAB M6 or M7 subtypes of leukemia, or adverse cytogenetics.
    • Remission is defined as < 5% blasts with no morphological characteristics of acute leukemia (e.g. Auer Rods) in a bone marrow with > 20% cellularity.
    • Biphenotypic/Undifferentiated leukemia in first or subsequent CR (same definition of CR as for ALL/AML).
    • Non-Hodgkin's lymphoma (T-cell, large cell or mantle cell) or Hodgkin's lymphoma in second or subsequent complete remission (CR) or in partial remission (PR) with documented chemosensitivity. In addition, marginal zone lymphoma or follicular lymphoma that has progressed after = 2 therapies (excluding single-agent rituximab). No history of prior myeloablative procedure.

    2. Lack of suitable 5-6/6 HLA-matched related or (if institutional guidelines dictate) suitable 8/8 HLA-A, B, C, DRß1 matched unrelated donor; or unrelated donor not available within appropriate timeframe.

    3. Age 15-65 years.

    4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

    5. Signed IRB approved Informed Consent Form (ICF).

    Exclusion Criteria:

    1. History of prior allogeneic transplantation

    2. Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction (Ejection fraction < 40%) as measured by gated radionuclide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension; history of myocardial infarction with depressed ejection fraction.

    3. Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected for hemoglobin.

    4. Renal disease: serum creatinine > 2.0 mg/dl and calculated creatinine clearance < 40 mL/min.

    5. Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's syndrome or ongoing hemolytic anemia), SGOT or SGPT > 5 x upper limit of normal.

    6. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation.

    7. HIV antibody.

    8. Uncontrolled infection.

    9. Pregnancy or breast feeding mother.

    10. Inability to comply with the requirements for care after allogeneic stem cell transplantation.

    Principal Investigator: Sumithira Vasu, MD

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  • open for enrollment

    A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma

    Protocol: OSU-10049

    Eligibility:

    Inclusion Criteria:

    • Histologically confirmed classical or lymphocyte predominant Hodgkin's lymphoma that is relapsed or refractory after at least one prior chemotherapy; patients with Hodgkin's lymphoma may have one of the following World Health Organization (WHO) subtypes:
    • Nodular sclerosis Hodgkin's lymphoma
    • Mixed cellularity Hodgkin's lymphoma
    • Lymphocyte-rich Hodgkin's lymphoma
    • Lymphocyte-deplete Hodgkin's lymphoma
    • Nodular Lymphocyte-predominant Hodgkin's lymphoma
    • Patients must have relapsed or progressed after at least one prior cytotoxic chemotherapy
    • Previous autologous or allogeneic stem cell transplantation is permitted
    • Previous treatment with either single agent panobinostat or lenalidomide is permitted
    • Absolute neutrophil count (ANC) >= 1200/µL
    • Platelets >= 100,000/µl
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit normal (ULN)
    • Serum bilirubin =< 1.5 x ULN
    • Calculated creatinine clearance >= 60ml/min by Cockcroft-Gault formula
    • Measurable Disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable; lesions that are considered non-measurable include the following:
    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Inflammatory breast disease
    • Lymphangitis cutis/pulmonis
    • Bone marrow involvement (involvement by non-Hodgkin lymphoma should be noted)
    • Baseline multi gated acquisition (MUGA) or echocardiogram (ECHO) must demonstrate left ventricular ejection fraction (LVEF) >= 45%
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
    • Able to provide written informed consent obtained prior to participation in the study and any related procedures being performed
    • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide (prescriptions must be filled within 7 days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
    • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant of aspirin or at increased risk of venous thrombosis may use warfarin or low molecular weight heparin)

    Exclusion Criteria:

    • Patients who are candidates for high dose chemotherapy and autologous stem cell transplantation with curative intent should not be enrolled
    • Patients with active central nervous system (CNS) lymphoma
    • Use of valproic acid for any medical condition while receiving protocol treatment or within 5 days prior to first panobinostat dose
    • Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
    • History or presence of sustained ventricular tachyarrhythmia; (patients with a history of atrial arrhythmia are eligible but should be discussed with Novartis prior to enrollment)
    • Any history of ventricular fibrillation or Torsade de Pointes
    • Bradycardia defined as heart rate (HR) < 50 beats per minute (bpm); patients with pacemakers are eligible if HR >= 50 bpm
    • Screening electrocardiogram (ECG) with a QTc > 450 msec
    • Right bundle branch block + left anterior hemiblock (bifascicular block)
    • Patients with myocardial infarction or unstable angina =< 6 months prior to starting study drug
    • Other clinically significant heart disease (e.g., congestive heart failure [CHF] New York [NY] Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
    • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat
    • Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
    • Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
    • Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
    • Known hypersensitivity to thalidomide
    • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
    • Pregnant or breastfeeding females
    • Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis C is not required
    • Concurrent use of other anti-cancer agents or treatments
    • Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff

    Principal Investigator: Kristie A Blum, MD, Affiliate

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  • open for enrollment

    Phase 1b Safety and Efficacy Study of TRU-016 and Rituximab or Obinutuzumab in Chronic Lymphocytic Leukemia

    Protocol: OSU-12095

    Eligibility:

    Inclusion Criteria:

    • Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk CLL
    • No prior therapy for CLL for Cohorts 1, 3 and 4. For Cohort 2, 1-3 prior treatments.
    • At least one of the following criteria for active disease requiring treatment: progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a 2-month period or an unanticipated doubling time of less than 6 months
    • For Cohorts 1, 3 and 4, contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference
    • Age >/= to 18 years
    • ECOG performance status of </= 2
    • Life expectancy > 6 months in opinion of Investigator
    • Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal
    • ANC >/= 800/mm3
    • Platelets >/= 30,000/mm3

    Exclusion Criteria:

    • For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL
    • Has received an investigational therapy within 30 days of first dose of study drug
    • Previous or concurrent additional malignancy
    • Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone marrow transplant, active autoimmune disease
    • Positive serology for HIV or hepatitis C
    • Hepatitis B surface antigen or hepatitis B core antibody positive
    • Pregnant or breastfeeding
    • Known current drug or alcohol abuse
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  • open for enrollment

    Phase I Dose Escalation Study of IMMU-114 in Relapsed or Refractory NHL and CLL

    Protocol: OSU-13004

    Eligibility:

    Inclusion Criteria:

    • Each patient with CLL/SLL must meet all of the following inclusion criteria to be enrolled on the study:
    • Patients must have met the diagnostic criteria for CLL/SLL according to the IWCLL 2008 [13] or WHO Guidelines at some point during their disease course:
    • Patients with SLL: tumor biopsy immunohistochemistry diagnostic of SLL or blood/bone marrow immunophenotype similar to CLL without lymphocytosis and enlarged lymph nodes.
    • Patient must have relapsed or refractory CLL/SLL following at least one purine analog-containing regimen (or after one non-purine analog containing regimen if there is a relative contraindication to purine-analog containing therapy) and not have traditional options available or decline these. Patients with prolymphocytic leukemia (PLL)-CLL or PLL transformation of CLL are eligible.
    • Patients must meet IWCLL 2008 Guideline [13] criteria for active disease requiring treatment.

    Each patient with NHL must meet all of the following inclusion criteria to be enrolled on the study:

    • Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.
    • Patients must have relapsed or refractory disease after at least one prior therapy and not have traditional options available or decline these.

    All patients must meet all of the following inclusion criteria to be enrolled on the study:

    •--Age=18 years

    • ECOG performance status <3
    • Patients must be able to receive outpatient treatment and follow-up at the treating institution.
    • Patients must have completed all prior therapies (immunosuppressive medications, antineoplastic therapy, vaccination, immunotherapy, chemotherapy, radiotherapy, etc) > 4 weeks prior to the first study dose of medication. Palliative corticosteroids for B-symptoms or corticosteroid therapy for treatment of autoimmune anemia and/or thrombocytopenia at a dose of <20mg daily.
    • Prior rituximab is permitted under the following conditions: Patients who are rituximab-refractory defined as having less than a partial response to the previous rituximab-containing regimen are eligible at any time. Patients who are rituximab-sensitive, defines as having a complete response or partial response to the last rituximab-containing regimen, are eligible at least 4 weeks after the last infusion of rituximab.
    • Patients who have relapsed after autologous stem cell transplant are eligible for the study. Patients who have relapse after allogeneic stem cell transplant are eligible for the study if the transplant occurred > 6 months prior to the study and the patient has no active graft versus host disease.
    • Patients capable of reproduction and male patients who have partners capable of reproduction must agree to use an effective contraceptive method during the course of the study and for 2 months following the completion of their last treatment. Females of childbearing potential must have a negative serum ß-hCG pregnancy test result within 3 days of first study dose. Female patients who are surgically sterilized or who are >45 years old and have not experienced menses for >2 years may have ß-hCG pregnancy test waived.
    • All patients will undergo screening for Hepatitis B, C, and HIV infection. Patients with a history of hepatitis B (surface antigen or core antibody positive) must take lamivudine or equivalent drug during study therapy and for one year after completion of all therapy. Patients with active hepatitis B or C infection are not eligible.
    • Required baseline laboratory data (If the following laboratory studies are abnormal secondary to the underlying malignancy as determined by the treating clinician, they will not be used as inclusion or exclusion criteria.)
    • Platelet count =50,000/mm3
    • Absolute neutrophil count (ANC) =500/mm3 (ANC quantitation is inaccurate in the presence of WBC >50,000/mm3 and therefore ANC in the setting of WBC >50,000/mm3 will not be utilized as an inclusion or exclusion criterion.)
    • Creatinine <2.0mg/dL
    • AST/AST =2.5 times upper limit of normal (ULN)
    • Total bilirubin =2.0 ULN
    • Patients must possess the ability to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:

    • Patients having received anti-CD20 therapy = 4 weeks prior to the first study dose.
    • Patients having received alemtuzumab (anti-CD52) therapy = 6 months prior to the first study dose.
    • Patients having undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease.
    • Patients with active Richter's syndrome (>10% large B-cells in marrow).
    • Patients that have been designated Class III or IV by the New York Heart Association Functional Classification.
    • Patients with a history of myocardial infarction or stroke within the last 6 months.
    • Patients with known hypersensitivity to any excipient contained in the drug formulation.
    • Patients with a history of documented human anti-globulin antibodies.
    • Patients with active viral, bacterial or systemic fungal infection requiring treatment.
    • Patients who are known to be HIV or hepatitis C positive.
    • Patients with a history of prior secondary malignancy that requires active systemic therapy that will interfere with interpretation of efficacy or toxicity of IMMU-114, or limit survival to 2 years. These patients should be discussed with the sponsor prior to enrollment. Patients with basal or squamous skin carcinoma, cervical carcinoma in situ on biopsy, localized breast cancer requiring hormonal therapy or localized prostate cancer (Gleason score < 5) do not require discussion.
    • Patients with active known CNS lymphoma. Patients with history of CNS leukemia now in remission are eligible for the trial.
    • Patients who are pregnant or breast-feeding.
    • Patients with major surgery or radiation therapy within 4 weeks prior to first study dose.
    • Patients must have recovered all toxicities from prior therapy or radiation to grade 1 or less (excluding alopecia).
    • Patients with substance abuse or other medical or psychiatric conditions that, in the opinion of the investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study.

    Principal Investigator: Beth A Christian, MD, Affiliate

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  • open for enrollment

    A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

    Protocol: OSU-10152

    Eligibility:

    Inclusion Criteria:

    • Subject has histologic or cytologic confirmation of advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
    • Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
    • Subject has resolution to grade =1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
    • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    • Subject has adequate hematologic, hepatic, renal, and coagulation function
    • Subject has a life expectancy greater than 3 months
    • Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy

    Exclusion Criteria:

    • Subject has experienced acute pathologic fracture, spinal cord compression, or clinically significant hypercalcemia within 28 days prior to first dose of study therapy
    • Subject has a known hypersensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-CS4.
    • Subject has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
    • Subject has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
    • Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm
    • Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder
    • Subject has known or suspected primary brain or leptomeningeal metastases
    • Subject has leukemia or lymphoma
    • Subject is know to have active tuberculosis, leishmaniasis, or listeriosis
    • Subjects with known history, or clinical or laboratory evidence of liver disease
    • Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
    • Subject if female, is pregnant or breastfeeding
    • Subject has received an organ transplant

    Principal Investigator: Robert Wesolowski, MD

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  • open for enrollment

    Study of BKM120 &amp; Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma

    Protocol: OSU-13027

    Eligibility:

    Inclusion Criteria:

    • Patients must have histologically confirmed indolent B-cell NHL or mantle cell lymphoma; acceptable subtypes of indolent B-cell NHL include follicular lymphoma (grades 1, 2, or 3a), marginal zone lymphoma, or lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia; patients with mantle cell lymphoma must have a documented t(11;14) or overexpression of cyclin D1 by immunohistochemical evaluation; patients with active large cell transformation are not eligible; however, patients with a history of large cell transformation are eligible provided that there is no current clinical evidence of active transformed lymphoma
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • At least one prior therapy; prior autologous or allogeneic stem cell transplant is allowed; patients may not be on chronic immunosuppressive therapy for graft-versus-host disease (GVHD); patients who have received prior treatment with a pan-selective PI3K inhibitor are not eligible; however, prior therapy with a selective PI3K inhibitor, Bruton's tyrosine kinase inhibitor, or other B-cell receptor targeting agents is allowed
    • Serum creatinine =< 2.0 mg/dL
    • Total bilirubin =< upper limit of normal
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper limit of normal
    • Absolute neutrophil count (ANC) >= 750/mm^3
    • Platelets >= 50,000/ mm^3
    • Serum lipase =< upper limit of normal
    • Serum amylase =< upper limit of normal
    • International normalized ratio (INR) =< 2.0
    • Fasting glucose < 120mg/dL
    • Recovery to =< grade 1 toxicities associated with prior therapy
    • Negative serum pregnancy test; if, on cycle 1 day 1, greater than 72 hours has elapsed since the last negative result, a serum pregnancy test must be repeated and be negative on cycle 1 day 1 (C1D1) for the patient to remain eligible
    • Patient has the ability and willingness to provide informed consent and has signed the informed consent document

    Exclusion Criteria:

    • Pregnant or breast-feeding women and women of childbearing age or men who are unwilling to use adequate contraception; females of childbearing age and potential (i.e., not surgically sterilized) must use a second form of contraception, including total abstinence, intra-uterine device, double-barrier contraception, or other non-hormonal form of contraception
    • Patients with a history of central nervous system involvement by lymphoma
    • The presence of co-existing medical conditions that would limit compliance with study medications, including, but not limited to active infection, active or untreated cardiac or pulmonary disease, or malignancy
    • Patients with significant, symptomatic deterioration of lung function confirmed by spirometry, diffusion capacity of carbon monoxide (DLCO), or resting oxygen (O2) saturation
    • Patients with impairment of gastrointestinal function that may alter the absorption of BKM120
    • Patients currently being actively treated or who have been treated within the past 3 years for an unrelated malignancy (except non-melanoma skin cancer, cervical carcinoma in-situ, and low risk prostate cancer)
    • Patients who have undergone major surgery within 2 weeks prior to study enrollment or who have not recovered from a major surgery
    • Patients with known human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active or carriers)
    • Patients with a fasting blood glucose >= 120 mg/dL (6.7mmol/L); patients with diabetes mellitus are eligible if they require oral agents only and have a fasting blood glucose =< 120 mg/dL; patients with a history of diabetes mellitus who require daily long-acting or mealtime insulin are not eligible; patients who have previously required treatment for hyperglycemia due to steroids or other medications are eligible as long as they have not required insulin or any other oral agent within 2 months prior to study enrollment
    • Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is >= 10mg prednisone
    • Patients with a known hypersensitivity to BKM120 or its excipients
    • Patients with active moderate or severe major mood or psychiatric disorder as judged by the investigator, primary care physician, counselor, psychiatrist, or as a result of the patient's mood assessment questionnaire that may interfere with the ability to comply with the trial; in addition, given the prior mood-associated toxicities, patients with a history of psychiatric hospitalization within the past 5 years, electroconvulsive therapy (ECT) within the past 5 years, or whose psychiatric condition has been unstable within 2 months prior to study enrollment requiring addition or change of psychotropic medications are not eligible; examples include, but are not limited to:
    • Medically documented history of or active major depressive episode requiring inpatient or intensive outpatient therapy, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or active ideation, or homicidal ideation (immediate risk of doing harm to others); patients under the care of a primary care physician who are treated with one oral agent and who have not required dose adjustments or new medications within 2 months prior to study enrollment and who otherwise meet eligibility requirements may be enrolled
    • >= Common Terminology for Adverse Events (CTCAE) version 4.0 grade 3 anxiety
    • Patients meeting the cutoff score of >= 12 in the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder-7 (GAD-7) mood scale, respectively, or who select a positive response of "1, 2, or 3" to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) are not eligible
    • Patients with diarrhea >= CTCAE grade 2
    • Patients with active cardiac disease including any of the following:
    • Left ventricular ejection fraction < 50% as determined by multi gated acquisition scan (MUGA) scan or echocardiogram
    • Corrected QT interval (QTc) > 480 msec on screening ECG (using the QTcF formula)
    • Active angina pectoris
    • Ventricular arrhythmias except for benign premature ventricular contractions
    • Supraventricular or nodal arrhythmias or any conduction abnormality requiring a pacemaker or automatic implantable cardioverter defibrillator (AICD)
    • Valvular disease with documented compromise in cardiac function
    • Symptomatic pericarditis
    • Myocardial infarction within the past 6 months
    • Congestive heart failure (New York Heart Association [NYHA] functional classification III-IV)
    • Patients who are currently receiving treatment with medications with a known risk to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to study enrollment
    • Patients who have taken herbal medications and certain fruits within 7 days prior to study enrollment are not eligible; herbal medications include, but are not limited to, St John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; exclusionary fruits include the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
    • Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to study enrollment; (please note that co-treatment with weak inhibitors of CYP3A is allowed)
    • Patients who have received oral or IV chemotherapy, targeted anticancer therapy or radiation therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to study enrollment
    • Patients who are currently taking therapeutic doses of warfarin sodium or any other Coumadin-derivative anticoagulant; patients who can be safely changed to enoxaparin or other non-warfarin derived anti-coagulant and who otherwise meet eligibility requirements may be enrolled
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  • open for enrollment

    BI 836858 Dose Escalation in Refractory or Relapsed Acute Myeloid Leukemia

    Protocol: OSU-12006

    Eligibility:

    Inclusion criteria:

    1. Diagnosis of relapsed or refractory AML with at least one prior treatment for acute myeloid leukemia.

    2. Expression of CD33 on more than 30% of bone marrow blasts.

    3. Eastern Cooperative Oncology Group Performance Status 0, 1 or 2

    4. Age 18 years or older

    5. Written informed consent which is consistent with International Conference on Harmonization ¿ Good Clinical Practice (ICH-GCP) guidelines and local legislation.

    Exclusion criteria:

    1. Patients with acute promyelocytic leukemia according to WHO definition.

    2. Patients with > 5.000 leukocytes/µl in the peripheral blood

    3. Anti-leukemia therapy within two weeks before first treatment with BI 836858, 4 weeks for biologics

    4. Allogeneic stem cell transplantation within the last 3 months or with evidence of graft versus host disease

    5. Patients who are candidates for allogeneic stem cell transplantation.

    6. Second malignancy currently requiring active therapy.

    7. Symptomatic central nervous system involvement

    8. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN), or AST or ALT greater than 5 times the ULN for those with Gilbert syndrome.

    9. Prothrombin time (PT) >1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)

    10. Bilirubin greater than 1.5 mg/dl (>26 µmol/L) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert syndrome, or hemolysis.

    11. Serum creatinine greater than 2.0 mg/dl

    12. Known human immunodeficiency virus (HIV) infection or active hepatitis B virus or hepatitis C virus infection.

    13. Concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia

    14. Psychiatric illness or social situation that would limit compliance with trial requirements

    15. Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug

    16. Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for 6 months after the last administration of BI 836858

    17. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception during the trial and for 6 months after the last administration of BI 836858

    18. Pregnant or nursing female patients

    19. Treatment with another investigational agent under the following conditions:

    1. Within two weeks (4 weeks for biologics) of first administration of BI 836858; or

    2. Patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the Investigator.

    3. Concomitant treatment with another investigational agent while participating in this trial.

    20. Prior treatment with a CD33 antibody

    21. Patient unable or unwilling to comply with the protocol.

    Principal Investigator: William G Blum, MD

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