Expired Study
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Detroit, Michigan 48201


Purpose:

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with imatinib mesylate in treating patients with chronic myelogenous leukemia.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with imatinib mesylate in patients with chronic myelogenous leukemia. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients receive oral imatinib mesylate on days 1-21 and 17-AAG IV over 1 hour on days 1, 4, 8, and 12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6-10 patients receives treatment at the recommended phase II dose. PROJECTED ACCRUAL: Approximately 21-42 patients will be accrued for this study within 1.5 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of chronic myelogenous leukemia, including any of the following phases: - Blastic phase - Greater than 30% blasts in the peripheral blood or bone marrow - Previously untreated disease OR refractory to or relapsed after most recent therapy - Accelerated phase, defined by 1 of the following: - At least 15, but less than 30%, blasts in the peripheral blood or bone marrow - At least 30% blasts and promyelocytes in the peripheral blood or bone marrow - Greater than 20% peripheral blood basophilia - Chronic phase - No major cytogenetic response (less than 65% Philadelphia chromosome negative) after 12 months of prior imatinib mesylate therapy - Philadelphia chromosome positive by routine cytogenetics PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal Renal - Creatinine less than 1.5 mg/dL Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known allergy to eggs - Able to swallow pills - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled medical illness PRIOR CONCURRENT THERAPY: Biologic therapy - No prior stem cell transplantation Chemotherapy - More than 4 weeks since prior chemotherapy (except hydroxyurea or anagrelide) (at least 6 weeks for nitrosoureas or mitomycin) Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - No prior liver, kidney, or lung transplantation - More than 14 days since prior major surgery (e.g., thoracotomy or intra-abdominal surgery) Other - Prior imatinib mesylate administered within the past 4 weeks is allowed - No concurrent tacrolimus or cyclosporine as immunosuppressive agents - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent agents that alter CYP3A4 activity, including any of the following: - Grapefruit juice - Ketoconazole - Fluconazole - Itraconazole - Erythromycin - Clarithromycin - Cimetidine - Terfenadine - Astemizole - HIV protease inhibitors (e.g., indinavir and nelfinavir)


NCT ID:

NCT00066326


Primary Contact:

Study Chair
Charles A. Schiffer, MD
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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