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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003837
First received: November 1, 1999
Last updated: June 18, 2013
Last verified: December 2005
  Purpose

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 Intervention
Leukemia
Lymphoma
Drug: nelarabine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Antitumor efficacy as defined by the rate of complete hematologic responses [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 1999
Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003837

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612
United States, Maryland
NCI - Pharmaceutical Management Branch
Bethesda, Maryland, United States, 20892
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5047
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Investigators
Study Chair: Anthony J. Murgo, MD NCI - Investigational Drug Branch
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003837     History of Changes
Other Study ID Numbers: CDR0000066994, CTEP-TRC-9701, CWRU-TRC-1499
Study First Received: November 1, 1999
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
recurrent adult lymphoblastic lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014