S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)|
- CR [ Time Frame: After induction therapy is completed ] [ Designated as safety issue: No ]
|Study Start Date:||July 2000|
|Study Completion Date:||July 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
- 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.