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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

    Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease

    Protocol: OSU-15270

    Eligibility:

    Inclusion Criteria: - New onset high risk acute GVHD (Ann Arbor score 3 as defined in Appendix C of the protocol) following allogeneic bone marrow transplantation. Any clinical severity (Glucksberg grade I-IV) is eligible. - Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible. - No prior systemic treatment for acute GVHD except for a maximum of 72 hours of prednisone ≤2 mg/kg/day (or IV methylprednisolone equivalent). Topical skin steroid treatment is permissible. Non-absorbable oral steroid treatment for GI GVHD is prohibited. - Age 12 years or older. - If the patient is a woman of child-bearing potential, the patient and their sexual partner must agree to practice effective contraception. - Written informed consent from patient, parent, or guardian. - Written assent from patients age 12 to 17 years. - Biopsy of acute GVHD target organ is strongly recommended, but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 72 hours of new onset acute GVHD are not permitted to participate. Exclusion Criteria: - Progressive or relapsed malignancy - Uncontrolled active infection - Patients with chronic GVHD - Known seropositivity for JC virus - History of Progressive Multifocal Leukoencephalopathy (PML) - Known hypersensitivity to natalizumab - Pregnant or nursing (lactating) women - Use of other drugs for the treatment of acute GVHD - Patients on dialysis - Patients requiring ventilator support - Investigational agent within 30 days of enrollment without approval from the Sponsor-Investigator

    Principal Investigator: Yvonne A Efebera, MD

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  • open for enrollment

    Pomalidomide and Dexamethasone with or without Ixazomib in Treating Patients with Refractory Multiple Myeloma

    Protocol: ALLIANCE-A061202

    Eligibility:

    Inclusion Criteria:

    Histologically confirmed diagnosis of symptomatic multiple myeloma; relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed

    Measurable disease

    Serum myeloma protein (M-protein) >= 1.0 g/dL (>= 0.5 g/dL for immunoglobulin A [IgA] myeloma) and/or

    Urine M-protein >= 200 mg/24 hours and/or

    Involved serum free light chain level >= 10 mg/dL AND an abnormal serum free light chain ratio and/or

    Baseline marrow burden of myeloma of at least 30%

    Please note: for patients participating in the phase II portion of the study who elect to cross-over from treatment Arm 1 to treatment Arm 2 at the time of disease progression, the serum M protein should be 0.5 g/dL or more if that is the parameter being followed to measure response

    Previously treated symptomatic multiple myeloma

    Lenalidomide AND proteasome inhibitor-refractory multiple myeloma (dual refractory disease):

    Please note: lenalidomide and proteasome inhibitor-refractory disease is defined as disease progression on or progression within 60 days of the last dose of a lenalidomide- AND proteasome inhibitor-based treatment; patients should have received at least 2 cycles of a lenalidomide- or proteasome inhibitor-based regimen at standard doses to be evaluable for refractoriness; patients can be refractory to any proteasome inhibitor–they do NOT need to be refractory to all available proteasome inhibitors; in addition, patients can be refractory to lenalidomide and proteasome inhibitors given sequentially as part of different lines of therapy OR therapy that includes a combination of lenalidomide and a proteasome inhibitor; please see the International Myeloma Working Group (IMWG) response criteria for progressive disease (PD)

    At least 2 or more prior lines of systemic therapy for multiple myeloma

    Please note: a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy); a new line of therapy begins when a planned therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, disease relapse or treatment-related toxicity (e.g. a patient is progressing in the face of lenalidomide maintenance therapy and has bortezomib and dexamethasone added into their regimen); a new line of therapy also begins when a planned treatment-free interval is interrupted by the need to start treatment due to disease relapse/progression (e.g. a patient with relapsed myeloma achieves a partial response after a planned 8 cycles of cyclophosphamide, bortezomib and dexamethasone, enjoys an 8-month period off therapy but then experiences disease progression requiring re-initiation of therapy)

    Allogeneic stem cell transplantation is allowed provided the patient is >= 1 year from transplant, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, no evidence of active infection and meets all other criteria for participation

    No other chemotherapy or radiation therapy within 14 days prior to registration

    No investigational agent within 21 days prior to registration

    Pomalidomide naive and pomalidomide sensitive disease are allowed during phase I and phase II

    Please note: Sensitivity to pomalidomide is defined as an MR or better to prior pomalidomide-based therapy that is maintained for >= 60 days from the last dose of therapy

    No concurrent investigational therapy

    No major surgery within 28 days prior to registration

    Patients cannot have received G-CSF (filgrastim) or GM-CSF (sargramostim) within 1 week of screening or pegfilgrastim within 2 weeks of screening to meet eligibility criteria

    Patients cannot have received a platelet transfusion within 7 days of screening to meet eligibility criteria; red blood cell transfusions are allowed at any time

    Non-pregnant and non-nursing:

    A female of childbearing potential is a sexually mature female who:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); please note the information below is strictly for eligibility purposes

    Therefore, women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mlU/ml no more than 14 days prior to therapy and repeated again within 24 hours of starting pomalidomide and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide; females of childbearing potential must also agree to ongoing pregnancy testing; men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy; all participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; participating women cannot be pregnant or nursing

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

    Absolute neutrophil count (ANC) >= 1.0 x 10^9/L

    Platelet count >= 50 x 10^9/L

    Calculated (Calc.) creatinine clearance >= 50 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection

    Total bilirubin < 1.5 x upper limits of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limits of normal (ULN)

    Patients cannot have:

    Central nerve system involvement

    Primary refractory multiple myeloma

    • Note: primary refractory multiple myeloma is defined as disease that is nonresponsive-patients who have never achieved an MR or better-with any therapy over the course of their disease; it includes patients who never achieve MR or better in whom there is no significant change in M-protein and no evidence of clinical progression as well as patients who meet criteria for true progressive disease (PD)

    Primary or secondary plasma cell leukemia

    Light-chain (AL) amyloidosis or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome

    Patients cannot have:

    Known active hepatitis C based on:

    +Hepatitis C virus (HCV) antibody (confirmed)

    +HCV ribonucleic acid (RNA)

    Liver disease with history of positive serology

    Known hepatitis B surface antigen positivity

    Patients cannot have had previous hypersensitivity to any of the components of the study treatment

    Patients cannot have had a prior history of erythema multiforme with thalidomide or lenalidomide treatment

    =< Grade 2 peripheral neuropathy

    Adequate cardiac function, defined as:

    No electrocardiogram (EKG) evidence of acute ischemia

    No EKG evidence of active, clinically significant conduction system abnormalities

    No EKG evidence of > grade 2 (> 480 ms) corrected QT (QTc) prolongation

    Prior to study entry, any EKG abnormality at screening not felt to put the patient at risk has to be documented by the investigator as not medically significant

    No uncontrolled angina or severe ventricular arrhythmias

    No clinically significant pericardial disease

    No history of myocardial infarction within the last 6 months

    No class 3 or higher New York Heart Association congestive heart failure

    Patients cannot be on strong inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2) or strong inhibitors of CYP3A4 or CYP1A2

    Note: Ixazomib is a substrate of CYP3A4 and CYP1A2

    Chronic concomitant treatment with strong CYP3A4 inducers is not allowed (e.g. phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s Wort); please note that drugs that strongly induce or inhibit CYP3A4 are not allowed; because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http://medicine.iupui.edu/clinpharm/ddis/; medical reference texts such as the Physicians’ Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product

    Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following:

    No history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV related illness

    Cluster of differentiation (CD)4+ cells nadirs > 350/mm^3

    Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm^3

    Please note: HIV+ patients who enroll on this study and are assigned to treatment with ixazomib may need to modify their anti-retroviral therapy prior to receiving protocol therapy if they are on strong inducers or potent inhibitors of cytochrome P450 3A4

    Principal Investigator: Yvonne A Efebera, MD

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  • open for enrollment

    Ph I Study of ACTR087 in Combo w/ SEA-BCMA in Subjects w/ Relapsed or Refractory Multiple Myeloma

    Protocol: OSU-17279

    Principal Investigator: Don M Benson, MD, PhD

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  • open for enrollment

    Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed/Refractory Multiple Myeloma

    Protocol: OSU-15260

    Eligibility:

    Inclusion Criteria:

    Evidence of disease progression:

    Symptomatic relapsed or refractory requiring current treatment.

    Previously treated with ≥ 3 prior regimens (lines of therapy) that included at

    least one of each of the following: alkylating agent, immunomodulatory drug,

    proteasome inhibitor, and a steroid.

    Must be refractory to most recent anti-cancer regimen.

    Must have measurable disease defined by one of the following:

    Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or for IgA

    myeloma, by quantitative IgA. If SPEP is felt to be unreliable for routine

    Mprotein measurement (e.g., for patients with IgA MM), then quantitative Ig

    levels by nephelometry or turbidometry are acceptable; or

    Urinary M-protein excretion at least 200 mg/24 hours; or

    Serum Free Light Chain (Serum FLC) whereby the involved light chain measures ≥

    10 mg/dL and with an abnormal ratio.

    Eastern Cooperative Oncology Group performance status of ≤ 1.

    Exclusion Criteria:

    Time since the last prior therapy:

    Radiation, chemotherapy, immunotherapy or any other anticancer therapy,

    including investigational anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1.

    Palliative steroids for disease related symptoms are allowed up to 3 days prior

    to Cycle 1 Day 1.

    Active graft versus host disease after allogeneic stem cell transplantation. At least

    3 months must have elapsed since completion of allogeneic stem cell transplantation.

    Active central nervous system malignancy. Patients who have only had prophylactic

    intrathecal or intravenous chemotherapy against central nervous system disease are

    eligible.

    Patients with significantly diseased or obstructed gastrointestinal tract or

    uncontrolled vomiting or diarrhea that could interfere with the absorption of

    KPT-8602.

    Prior exposure to XPO1 inhibitors.

    Life expectancy of ≥ 4 months.

    Principal Investigator: John L Hays, MD, PhD

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  • open for enrollment

    Ph I/II Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects with Relapsed or Refractor

    Protocol: OSU-18100

    Principal Investigator: Ashley Rosko, MD

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  • open for enrollment

    Ph I/IIa Melflufen and Dexamethasone in Com w/ Bortezomib or Daratumumab in Pts w/ Relapsed/ Relapse

    Protocol: OSU-17369

    Principal Investigator: Yvonne A Efebera, MD

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