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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This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of accrual per Center DSMP, with PI concurrence)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01011998
First received: November 5, 2009
Last updated: September 23, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Myelogenous Leukemia
 Drug: Gleevec (imatinib), valproic acid
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Imatinib and Valproic Acid in Patients With CML

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

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 ]

Enrollment: 0
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gleevec (imatinib), valproic acid

    Valproic acid: 250 mg three times per day and then adjusted according to attain a therapeutic level.

    Gleevec will be continued at the dose the patient was taking at the time of entry onto the study.

    Other Names:
    • Valproic acid
    • Imatinib
    • Gleevec
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011998

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Ian Rabinowitz, MD University of New Mexico Cancer Center
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01011998     History of Changes
Other Study ID Numbers: INST 0901
Study First Received: November 5, 2009
Last Updated: September 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
CML
Chronic Myelogenous leukemia
INST 0901
 imatinib
valproic acid
Gleevec

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Valproic Acid
Imatinib
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antineoplastic Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013