Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
nelarabine
Hematologic Diseases+9
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: September 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
City of Hope Comprehensive Cancer Center
Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google MapsH. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, United StatesNCI - Pharmaceutical Management Branch
Bethesda, United StatesBarbara Ann Karmanos Cancer Institute
Detroit, United States