A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of accrual per Center DSMP, with PI concurrence)
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
First received: November 5, 2009
Last updated: September 23, 2011
Last verified: July 2011
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.
Chronic Myelogenous Leukemia
Drug: Gleevec (imatinib), valproic acid
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Imatinib and Valproic Acid in Patients With CML
Primary Outcome Measures:
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011998
|University of New Mexico Cancer Center
|Albuquerque, New Mexico, United States, 87106 |
New Mexico Cancer Care Alliance
||Ian Rabinowitz, MD
||University of New Mexico Cancer Center
No publications provided
||New Mexico Cancer Care Alliance
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 5, 2009
||September 23, 2011
||United States: Institutional Review Board
Keywords provided by New Mexico Cancer Care Alliance:
Chronic Myelogenous leukemia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2014
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Bone Marrow Diseases
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Protein Kinase Inhibitors