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This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of accrual per Center DSMP, with PI concurrence)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

November 5, 2009
September 23, 2011
September 2009
June 2010   (final data collection date for primary outcome 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01011998 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
A Phase II Study of Imatinib and Valproic Acid in Patients With CML

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myelogenous Leukemia
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011998
INST 0901
No
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Ian Rabinowitz, MD University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP