Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Phase 2

Completed

• Conditions: Leukemia
• Interventions: Biological: recombinant interferon alfa; Drug: omacetaxine mepesuccinate

• Registration Number: NCT00002574
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Phase II trial to study the effectiveness of homoharringtonine and interferon alfa in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.

Detailed Description

OBJECTIVES:

I. Determine the efficacy of homoharringtonine administered simultaneously with interferon alpha in achieving complete cytogenetic response in patients with chronic myelogenous leukemia in chronic phase.

OUTLINE:

Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.

Study Timeline

• Study Start: 1994-09
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-06
• Status Verified: 2001-10
• Study First Submitted QC: 2004-08-09
• Study First Posted: 2004-08-10
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	recombinant interferon alfa	Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.
Arm I	omacetaxine mepesuccinate	Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States