506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents

Phase 2

Completed

• Conditions: Leukemia

• Registration Number: NCT00003635
• Lead Sponsor: GlaxoSmithKline

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 with chronic lymphocytic leukemia that has not responded to fludarabine or alkylating agents.

Detailed Description

OBJECTIVES: I. Determine the anticancer efficacy of 506U78 in patients with chronic lymphocytic leukemia refractory to fludarabine and alkylator therapy. II. Determine the safety (including incidence of infection) of this drug in these patients. III. Evaluate the pharmacokinetics of 506U78 and ara-G, and assess the intracellular pharmacokinetics of ara-GTP in patients receiving multiple treatment courses (at M.D. Anderson Cancer Center only). IV. Determine the response rate, time to maximal response, and duration of response in patients treated with this drug. V. Determine two-year survival and progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to cellular type of disease (B cell vs T cell). Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 28 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days and then every 2 months for 2 years until disease progression. After disease progression, patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 14-100 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-01
• Study First Submitted: 1999-11-01
• Status Verified: 2002-01
• Study Completion: 2004-03
• Study First Submitted QC: 2004-03-30
• Study First Posted: 2004-03-31
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (22)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Sidney Kimmel Cancer Center; 🇺🇸 San Diego, California, United States

Clinical Studies, Ltd.; 🇺🇸 Denver, Colorado, United States

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

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