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

National Cancer Institute (NCI)25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Leukemia Lymphoma

Interventions

nelarabineDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (7)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

NCI - Pharmaceutical Management Branch

Bethesda, Maryland, United States

Barbara Ann Karmanos Cancer Institute

Outcomes

Primary Outcomes

Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority

Secondary Outcomes

Toxicity

Antitumor efficacy as defined by the rate of complete hematologic responses

Data from ClinicalTrials.gov

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