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S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

Phase 2
Completed
Conditions
Leukemia
Registration Number
NCT00006020
Lead Sponsor
SWOG Cancer Research Network
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 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia.

Detailed Description

OBJECTIVES:

* Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78.

* Determine the frequency and severity of toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
CRAfter induction therapy is completed
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (107)

MBCCOP - Gulf Coast

πŸ‡ΊπŸ‡Έ

Mobile, Alabama, United States

CCOP - Western Regional, Arizona

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan)

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Duarte, California, United States

Veterans Affairs Medical Center - Long Beach

πŸ‡ΊπŸ‡Έ

Long Beach, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

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MBCCOP - Gulf Coast
πŸ‡ΊπŸ‡ΈMobile, Alabama, United States

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