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.

Condition	Treatment or Intervention
recurrent adult acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia recurrent adult lymphoblastic lymphoma	Drug: nelarabine  Procedure: chemotherapy

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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

California
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States; Recruiting
Illinois
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Maryland
      Pharmaceutical Management Branch, Rockville,  Maryland,  20852,  United States; Recruiting
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States; Recruiting
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States; Recruiting

Study chairs or principal investigators

Anthony Murgo, MD,  Study Chair,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000066994; CTEP-TRC-9701; CWRU-TRC-1499
Record last reviewed:  November 1999
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003837
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-22