STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cytarabine; Imatinib Mesylate

Criteria

Inclusion Criteria:

• Diagnosis of chronic myelogenous leukemia in myeloid blast crisis

• At least 30% blasts in bone marrow

• Philadelphia chromosome positive by cytogenetic analysis

• bcr/abl translocation by fluorescent in situ hybridization

• Ineligible for or refused allogeneic stem cell transplantation

• Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart

• Performance status - ECOG 0-2

• See Disease Characteristics

• Bilirubin less than 3 times upper limit of normal (ULN)

• AST and ALT less than 3 times ULN

• Creatinine less than 2 times ULN

• No New York Heart Association class III or IV heart disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients

• See Disease Characteristics

• No prior allogeneic bone marrow or peripheral blood stem cell transplantation

• At least 48 hours since prior interferon alfa

• At least 24 hours since prior hydroxyurea

• At least 6 weeks since prior busulfan

• No other prior chemotherapy for blast crisis (except hydroxyurea)

• Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed

• At least 4 weeks since prior investigational agents