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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)

Conditions
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Leukemia

Intervention / Treatment
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* Drug: nelarabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nelarabine|1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR |  | After induction therapy is completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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