506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

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: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

Detailed Description
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OBJECTIVES: Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority. Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients. Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients. OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for one year and then every 6 months until death. PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.

Official Title
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Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Drug: nelarabine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma Tumor cells should exhibit phenotypic characteristics of these diseases No CNS involvement requiring intrathecal or craniospinal radiotherapy Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-3 OR Karnofsky 40-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: No neuropathy grade 2 or higher No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy No active seizure disorder No active infection No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior bone marrow transplantation allowed No concurrent allogeneic bone marrow transplantation Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered No prior 506U78 Endocrine therapy: No concurrent systemic steroid therapy Radiotherapy: See Disease Characteristics Prior radiotherapy allowed Surgery: Not specified Other: No other concurrent investigational therapy No concurrent treatment for seizures

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nelarabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Antitumor efficacy as defined by the rate of complete hematologic responses |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, recurrent adult lymphoblastic lymphoma