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

NCT ID: NCT00003837

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2007-11-30

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.

Conditions

Leukemia; Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

nelarabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Anthony J. Murgo, MD

Role: STUDY_CHAIR

NCI - Investigational Drug Branch

Locations

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

Detroit, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CTEP-TRC-9701

Identifier Type: -

Identifier Source: secondary_id

CWRU-TRC-1499

Identifier Type: -

Identifier Source: secondary_id

CDR0000066994

Identifier Type: -

Identifier Source: org_study_id