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

Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Leukemia
• Intervention / Treatment: Drug: nelarabine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • NCI - Pharmaceutical Management Branch
  • Michigan
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44106-5047
      • Case Comprehensive Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Toxicity
Antitumor efficacy as defined by the rate of complete hematologic responses

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Study Chair: Anthony J. Murgo, MD, NCI - Investigational Drug Branch

Study record dates

Study Major Dates

• Study Start: September 1, 1999
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (ESTIMATE): January 27, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: December 1, 2005

More Information

Terms related to this study

• Keywords: recurrent adult lymphoblastic lymphoma; recurrent adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Lymphoid; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: CDR0000066994; CTEP-TRC-9701; CWRU-TRC-1499