NCT00006364

Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Phase I and Pilot Study of Subcutaneous Homoharringtonine in Chronic Myelogenous Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Childhood Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Phase Chronic Myelogenous Leukemia
• Relapsing Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	omacetaxine mepesuccinate	Given IV or SC
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 1999-11-01
• Primary completion: 2005-09-01
• First posted: 2003-01-27
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States