Leukemia, Lymphoma
Conditions
Keywords
recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, recurrent adult lymphoblastic lymphoma
Brief summary
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
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.
Interventions
DRUGnelarabine
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Toxicity | — |
| Antitumor efficacy as defined by the rate of complete hematologic responses | — |
Countries
United States
Outcome results
None listed