Vorinostat After Stem Cell Transplant in Treating Patients With High-Risk Lymphoma

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, and may stimulate the immune system to stop cancer cells from growing.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat after stem cell transplant in treating patients with high-risk lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Vorinostat

Criteria

DISEASE CHARACTERISTICS:

• Must have received a BEAM (cytarabine, etoposide, melphalan, carmustine)-conditioned autologous stem cell transplantation for any of the following high-risk lymphomas:

• Diffuse large B-cell lymphoma as defined by:

• Induction failure but with response to salvage therapy

• Relapse less than one year after completion of induction therapy

• Elevated lactate dehydrogenase (LDH) at relapse

• Stage III/IV disease at relapse

• Positive PET scan after induction or salvage therapy

• Age ≤ 75 and ≥ 60 years

• Follicular lymphoma as defined by:

• Progressive disease after two or more prior regimens

• Transformed to aggressive lymphoma but still chemotherapy sensitive

• Not felt to be a good candidate for an allogeneic transplantation

• Hodgkin lymphoma as defined by:

• Primary refractory disease

• Relapse less than one year after completion of induction therapy

• Relapse with PET-positive disease after salvage therapy

• Relapsed refractory and not felt to be a good candidate for an allogeneic transplantation

• Mantle cell lymphoma

• Chemotherapy-sensitive disease after induction therapy

• Chemotherapy-sensitive relapsed disease and not felt to be a good candidate for an allogeneic transplantation

• T-cell non-Hodgkin lymphoma (NHL)

• Peripheral T-cell lymphoma not otherwise specified and one or more of the following at diagnosis:

• High LDH

• Marrow involvement

• Age > 60 years

• Low platelet count

• Relapsed chemotherapy-sensitive disease

• Angioimmunoblastic lymphadenopathy with dysproteinemia

• Anaplastic lymphoma kinase-negative anaplastic NHL

• Enteropathy-associated T-cell NHL

• Natural killer (NK)/T-cell NHL and stage III/IV disease at diagnosis

• NK blastic NHL

PATIENT CHARACTERISTICS:

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

• ANC (absolute neutrophil count) ≥ 1,000/μL

• Platelet count ≥ 75,000/μL

• Total bilirubin ≤ 1.5 mg/dL

• AST (aspartate aminotransferase)/ALT (Alanine transaminase) ≤ 2 x upper limit of normal (ULN)

• Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 50 mL/min

• No severe or uncontrolled systemic illness

• Patients must be able to swallow capsules

• Negative pregnancy test

• Not pregnant or nursing

• Fertile patients must use at least two adequate barrier methods of contraception during study and for 90 days after completion of study therapy

• No other malignancy within the past 5 years other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy considered by their physician to be at less than 30% risk of relapse

• No congenital long QT syndrome

• No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, or uncontrolled congestive heart failure)

• No active bacterial, fungal, or viral infection

• No known HIV infection

• No active hepatitis B and/or hepatitis C infection

• No other medical condition, including mental illness or substance abuse, deemed by the Investigator(s) to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

PRIOR CONCURRENT THERAPY:

• Recovered from the majority of the toxicities from the autologous transplantation (must have returned to their pretransplant baseline or have no greater than grade I extramedullary toxicity Common Toxicity Criteria for Adverse Effects[CTCAE 3.0])

• No prior treatment with a histone deacetylase (HDAC) inhibitor (e.g., depsipeptide, MS-275, LAQ-824, belinostat, valproic acid)

• More than 4 weeks since prior and no concurrent class Ia, Ib, or Ic antiarrhythmic drugs

• No other concurrent antineoplastic chemotherapy or biologic therapy

• No concurrent radiotherapy, unless for local control of bone pain

• Irradiated area for pain management should be as small as possible and lesions within the irradiated field cannot be used for response

• No concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of vorinostat (SAHA)