This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

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

Secondary Outcome Measures:
  • Toxicity
  • Antitumor efficacy as defined by the rate of complete hematologic responses

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


  • 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 older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 16 and over

Performance status:

  • ECOG 0-3 OR
  • Karnofsky 40-100%

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • 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


Biologic therapy:

  • Prior bone marrow transplantation allowed
  • No concurrent allogeneic bone marrow transplantation


  • 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


  • See Disease Characteristics
  • Prior radiotherapy allowed


  • Not specified


  • No other concurrent investigational therapy
  • No concurrent treatment for seizures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003837

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
National Cancer Institute (NCI)
Study Chair: Anthony J. Murgo, MD NCI - Investigational Drug Branch
  More Information Identifier: NCT00003837     History of Changes
Other Study ID Numbers: CDR0000066994
Study First Received: November 1, 1999
Last Updated: June 18, 2013

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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on August 21, 2017