Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

Phase 1

Completed

• Conditions: Leukemia

• Registration Number: NCT00053248
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.

Detailed Description

OBJECTIVES:

* Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia.

* Determine potential dose-limiting toxic effects in patients treated with this regimen.

* Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least 12 patients for phase II) will be accrued for this study .

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2003-01-27
• Study First Submitted QC: 2003-01-27
• Study First Posted: 2003-01-28
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2010-06
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics
Satey and Tolerability
Dose-limiting toxicity

Trial Locations

Locations (3)

UCLA Department of Medicine, Division of Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States