Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

Phase 2

Terminated

• Conditions: Leukemia
• Interventions: Drug: Arsenic Trioxide

• Registration Number: NCT00006092
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.

Detailed Description

OBJECTIVES:

* Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.

* Determine the duration of hematologic response and overall survival of these patients when treated with this regimen.

* Determine the pattern of clinical adverse experience in these patients when treated with this regimen.

* Determine the pharmacokinetic profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.

Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2000-08-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arsenic Trioxide Treatment	Arsenic Trioxide	Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.

Primary Outcome Measures

Name	Time	Method
Objective Rate of Response (ORR)	2.5 years	Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.

Trial Locations

Locations (1)

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