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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01011998
Other study ID # INST 0901
Secondary ID
Status Withdrawn
Phase Phase 2
First received November 5, 2009
Last updated September 23, 2011
Start date September 2009
Est. completion date July 2010

Study information

Verified date July 2011
Source New Mexico Cancer Care Alliance
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of New Mexico Cancer Center Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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