A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)
A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)
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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphocytic leukemia (ALL)
Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)
Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed
Meeting 1 of the following criteria for recurrent/refractory disease:
No CNS involvement
Must be registered on SWOG-S9910 and SWOG-9007
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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