Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate

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)