STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.

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

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Daunorubicin; Imatinib Mesylate; Prednisone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• One of the following diagnoses:

• Chronic myelogenous leukemia in lymphoid blast crisis

• Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction

• No more than 1 prior course of induction chemotherapy

• Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization

• At least 30% blasts in bone marrow

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

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

• ALT and AST less than 3 times ULN

Renal:

• Creatinine less than 2 times ULN

Cardiovascular:

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

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

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

• At least 48 hours since prior interferon alfa

Chemotherapy:

• See Disease Characteristics

• At least 24 hours since prior hydroxyurea

• At least 6 weeks since prior busulfan

• Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No prior therapy for blast crisis except hydroxyurea

• No prior salvage or reinduction therapy for Ph+ ALL

• At least 4 weeks since other prior investigational agents