Relapsing Chronic Myelogenous Leukemia Clinical Trial
Official title:
Phase I and Pilot Study of Subcutaneous Homoharringtonine in Chronic Myelogenous Leukemia
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
OBJECTIVES:
I. Determine the maximum tolerated dose of homoharringtonine in patients with transformed
phases of chronic myelogenous leukemia (CML). (Phase I completed as of 2/11/2004.) II.
Determine the toxicity profile of this drug in these patients. III. Determine the response
duration in patients with chronic phase CML treated with this drug.
IV. Compare the pharmacokinetics of this drug administered as a continuous infusion vs
subcutaneously in these patients.
OUTLINE: This is a pilot, dose-escalation study. (Phase I completed as of 2/11/2004.)
Remission induction therapy: Patients receive remission induction therapy comprising
homoharringtonine IV continuously over 24 hours on day 1 and then subcutaneously (SC) twice
daily on days 2-14 for course 1. Subsequent courses of remission induction therapy comprise
homoharringtonine SC twice daily on days 1-14. Treatment continues monthly for at least 2
courses.
Maintenance therapy: Patients with complete hematologic remission receive maintenance
therapy comprising homoharringtonine SC twice daily on days 1-7 monthly for 3 years in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of homoharringtonine until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients
experience dose-limiting toxicity. An additional cohort of 25-30 patients with chronic phase
chronic myelogenous leukemia receives remission induction and maintenance therapy as above
at the MTD. (Phase I completed as of 2/11/2004.)
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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