- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016990
Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia
Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL
RATIONALE: Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It may also help cancer cells become more like normal cells, and grow and spread more slowly.
PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with previously treated non-Hodgkin Lymphoma, Hodgkin lymphoma, or chronic lymphocytic leukemia.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- To determine if valproic acid has a response rate of ≥ 20% in patients with previously treated relapsed or refractory non-Hodgkin lymphoma, Hodgkin lymphoma, or chronic lymphocytic leukemia.
- To determine if treatment with valproic acid leads to measurable levels of histone acetylation in peripheral blood.
OUTLINE: Patients are stratified according to disease diagnosis (indolent non-Hodgkin lymphoma [NHL] vs. aggressive NHL and Hodgkin lymphoma). Valproic acid doses are adjusted until therapeutic level is achieved.
Patients receive oral valproic acid daily for 3 weeks. Treatment repeats every 3 weeks for at least 2 courses and up to 2 years in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically. Samples are analyzed for valproic acid levels; and hyperacetylation (caused by the valproic acid N-terminals of the histones H3 and H4) via western blot.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00936-2712
- Recruiting
- Centro de Cancer del Hospital Auxilio Mutuo
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Contact:
- Contact Person
- Phone Number: 787-771-7933
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Diagnosis of relapsed or refractory Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), or chronic lymphocytic leukemia (CLL )
- Patient must have evaluable or measurable disease
Have failed prior treatment, as evidenced by 1 of the following:
Aggressive NHL
- Failed at least 1 regimen containing rituximab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) (unless anthracyclines are contraindicated) in addition to another salvage regimen (unless it is determined by the treating physician that it is to the patient's best interest to receive valproic acid after the first relapse)
Hodgkin lymphoma
- Failed ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and received salvage chemotherapy with at least 1 salvage combination regimen
Indolent or low-grade lymphoma
- Failed at least 1 combination regimen containing rituximab (patients who are intolerant to the available therapies or have contraindications for them are eligible for the study)
- No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/µL
- AST and ALT ≤ 3 times upper limit of normal
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 1.5 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- More than 14 days since prior anticancer treatment
- Prior high-dose chemotherapy with transplant allowed
- No prior valproic acid
- No concurrent corticosteroids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Response to therapy (complete response, partial response, or stable disease)
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Secondary Outcome Measures
Outcome Measure |
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Time to treatment failure
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Length of response
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Survival duration
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fernando Cabanillas, MD, Auxilio Mutuo Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult Burkitt lymphoma
- AIDS-related peripheral/systemic lymphoma
- AIDS-related diffuse large cell lymphoma
- AIDS-related immunoblastic large cell lymphoma
- AIDS-related small noncleaved cell lymphoma
- AIDS-related diffuse mixed cell lymphoma
- AIDS-related diffuse small cleaved cell lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse mixed cell lymphoma
- AIDS-related lymphoblastic lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- Waldenström macroglobulinemia
- peripheral T-cell lymphoma
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Leukemia
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
Other Study ID Numbers
- CDR0000659192
- CCAM-HDACI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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