Clinical Trial: 506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Detailed Summary:
OBJECTIVES:
- Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
- Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
- Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.
OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for one year and then every 6 months until death.
PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
Original Primary Outcome:
Current Secondary Outcome:
- Toxicity
- Antitumor efficacy as defined by the rate of complete hematologic responses
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: November 1, 1999
Date Started: September 1999
Date Completion:
Last Updated: June 18, 2013
Last Verified: December 2005