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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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 who have recurrent or refractory acute lymphocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)

Criteria

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