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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066326 |
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.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: imatinib mesylate Drug: tanespimycin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study Of The Combination Of 17-AAG And Imatinib Mesylate (Gleevec) In Patients With Blastic Phase, Accelerated Phase Of Chronic Mesylate Leukemia (CML) Or Patients With Chronic Phase CML Who Have Not Achieved A Cytogenetic Response With Imatinib Mesylate |
Study Start Date: | June 2003 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia, including any of the following phases:
Blastic phase
Accelerated phase, defined by 1 of the following:
Chronic phase
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent agents that alter CYP3A4 activity, including any of the following:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15213-1863 |
Study Chair: | Charles A. Schiffer, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000315521, WSU-C-2599, NCI-5932 |
Study First Received: | August 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00066326 History of Changes |
Health Authority: | United States: Federal Government |
blastic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Philadelphia Chromosome Blast Crisis Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Protein Kinase Inhibitors |
Imatinib Leukemia Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Bone Marrow Diseases |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Protein Kinase Inhibitors |
Pharmacologic Actions Imatinib Leukemia Neoplasms Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |