A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
Information source: New Mexico Cancer Care Alliance
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Myelogenous Leukemia
Intervention: Gleevec (imatinib), valproic acid (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: New Mexico Cancer Care Alliance Official(s) and/or principal investigator(s): Ian Rabinowitz, MD, Principal Investigator, Affiliation: University of New Mexico Cancer Center
Summary
The aim of this study is to test the effect of the combination of valproate in combination
with imatinib with an aim of achieving a maximal molecular response as the primary goal.
Clinical Details
Official title: A Phase II Study of Imatinib and Valproic Acid in Patients With CML
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To measure the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.
Detailed description:
The aim of this study is to test the effect of the combination of valproate in combination
with imatinib with an aim of achieving a maximal molecular response as the primary goal.
Briefly, patients with CML who are taking imatinib and have been found to have a plateau in
their level of the bcr-abl transcript will be eligible to participate in the study.
Valproate will then be added to the imatinib, and subsequent bcr-abl transcripts will be
monitored to see if the addition of valproate produced a further reduction. Patients will be
monitored for efficacy and toxicity.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All patients, 18 years of age or older, with a diagnosis of CML.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have an ECOG performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1. 5 x upper limit of normal.
- Patients with CML in chronic phase on imatinib as first line therapy who fulfill the
following criteria:
- The patient has at least two tests for quantitative reverse transcriptase polymerase
chain reaction (RT-PCR) for bcr-abl (peripheral blood or bone marrow aspirate). The
results of these tests should demonstrate a relative plateau in the effect of
imatinib on the detected level of the transcript (i. e. there should less than a ½ log
difference between the last two values). Note: Patients will be eligible if the more
recent study is greater than the previous study by any value.
- The last two quantitative RT-PCR studies should be at least 3 months apart.
- The patient should have received at least 9 months of imatinib since the diagnosis of
CML.
- The patient is tolerating imatinib without any grade 3 or greater toxicity.
Exclusion Criteria:
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.
- Patients who have a hypersensitivity to valproic acid, derivatives, or any component
of the formulation. Patients with hepatic disease or significant impairment, or urea
cycle disorders
Locations and Contacts
University of New Mexico Cancer Center, Albuquerque, New Mexico 87106, United States
Additional Information
Starting date: September 2009
Last updated: September 23, 2011
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