Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

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

Summary

Phase II trial to study the effectiveness of homoharringtonine in treating patients who have chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as homoharringtonine, work in different ways to stop cancer cells from dividing so they stop growing or die

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Harringtonines; Homoharringtonine

Criteria

Inclusion Criteria:

• Diagnosis of chronic phase chronic myelogenous leukemia (CML), as defined by the following:

• Less than 15% blasts in the peripheral blood (PB) or bone marrow (BM)

• Less than 20% basophils in the PB or BM

• Platelet count > 100,000/mm^3 (unless related to therapy)

• Absence of clonal evolution*

• Philadelphia chromosome- OR BCR/ABL-positive disease by cytogenetics, fluorescence in situ hybridization, or polymerase chain reaction

• Failed prior therapy with imatinib mesylate, as defined by any of the following:

• Failed to achieve or have lost a complete hematologic remission after 3 months of therapy

• Failed to achieve or have lost at least a minimal cytogenetic response after 6 months of therapy

• Failed to achieve or have lost a major or complete cytogenetic response after 12 months of therapy

• Unable to tolerate imatinib mesylate despite adequate dose adjustment

• Failed no more than 2 prior treatment regimens (in addition to imatinib mesylate)

• Treatment with hydroxyurea is not considered one regimen

• Ineligible for known regimens or protocols of higher efficacy or priority

• Performance status - Zubrod 0-2

• At least 2 months

• Bilirubin no greater than 2.0 mg/dL

• Creatinine less than 2.0 mg/dL

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

• Not pregnant or nursing

• Fertile patients must use effective contraception