A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)

NCT01011998 | Withdrawn Phase 2

• 1 other identifier: INST 0901
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myelogenous Leukemia

Keywords

CML; Chronic Myelogenous leukemia; INST 0901; imatinib; valproic acid; Gleevec

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Interventions

Gleevec (imatinib), valproic acid DRUG

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.

Also known as: Valproic acid, Imatinib, Gleevec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate; Valproic Acid

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pentanoic Acids; Valerates; Acids, Acyclic; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Ian Rabinowitz, MD

  University of New Mexico Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 11, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 27, 2011

Record last verified: 2011-07

Locations

US (1)