STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

NCT ID: NCT00015834

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31

Brief 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

Detailed Description

OBJECTIVES:

I. Determine the maximum tolerated dose of high-dose cytarabine when combined with imatinib mesylate in patients with blastic phase chronic myelogenous leukemia.

II. Determine the safety of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the frequency of hematologic and cytogenetic responses, duration of response, and survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of cytarabine.

Phase I: Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity.

Phase II: Additional patients are treated at the dose level preceding the MTD. Patients are followed monthly.

Conditions

Blastic Phase Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Relapsing Chronic Myelogenous Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (imatinib mesylate, cytarabine)

Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Given PO

cytarabine

Intervention Type: DRUG

Given IV

Interventions

imatinib mesylate

Given PO

Intervention Type: DRUG

cytarabine

Given IV

Intervention Type: DRUG

Other Intervention Names

CGP 57148; Gleevec; Glivec; ARA-C; arabinofuranosylcytosine; arabinosylcytosine; Cytosar-U; cytosine arabinoside

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Paquette

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles (UCLA )

Locations

University of California at Los Angeles (UCLA )

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-0011009

Identifier Type: -

Identifier Source: secondary_id

CDR0000068441

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02374

Identifier Type: -

Identifier Source: org_study_id