Leukemia
Conditions
Keywords
recurrent adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, B-cell adult acute lymphoblastic leukemia, non-T, non-B adult acute lymphoblastic leukemia
Brief 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.
Detailed description
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.
Interventions
DRUGnelarabine
1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR | After induction therapy is completed |
Countries
United States
Outcome results
None listed