Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia
NCT ID: NCT01016990
Last Updated: 2014-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
52 participants
INTERVENTIONAL
2009-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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valproic acid
western blotting
laboratory biomarker analysis
pharmacological study
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Auxilio Mutuo Cancer Center
OTHER
Principal Investigators
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Fernando Cabanillas, MD
Role: PRINCIPAL_INVESTIGATOR
Auxilio Mutuo Cancer Center
Locations
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Centro de Cancer del Hospital Auxilio Mutuo
San Juan, , Puerto Rico
Countries
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Facility Contacts
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Contact Person
Role: primary
Other Identifiers
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CCAM-HDACI
Identifier Type: -
Identifier Source: secondary_id
CDR0000659192
Identifier Type: -
Identifier Source: org_study_id
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