- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066326
Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia
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
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Charles A. Schiffer, MD, Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- CDR0000315521
- P30CA022453 (U.S. NIH Grant/Contract)
- U01CA062487 (U.S. NIH Grant/Contract)
- WSU-C-2599
- NCI-5932
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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