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

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.

DISEASE CHARACTERISTICS:

• Diagnosis of acute lymphocytic leukemia (ALL)

• FAB class L1-L2
• Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)

• Coexpression of myeloid antigens CD13 or CD33 allowed
• Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed

• CD3 and myeloperoxidase marker negative
• Meeting 1 of the following criteria for recurrent/refractory disease:

• Refractory to standard induction regimen including at least vincristine and prednisone
• Recurrence after response after prior induction therapy
• Recurrence and failure on subsequent treatment
• No CNS involvement
• Must be registered on SWOG-S9910 and SWOG-9007

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• Zubrod 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 3 times ULN

Renal:

• Creatinine no greater than 2 times ULN

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No grade 2 or greater neuropathy
• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified