Clinical trial NCT01011998: A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
Official title: A Phase II Study of Imatinib and Valproic Acid in Patients With CML
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Myelogenous Leukemia
Keywords: CML
Chronic Myelogenous leukemia
INST 0901
imatinib
valproic acid
Gleevec
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Ian Rabinowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: