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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003837
First Posted: January 27, 2003
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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

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:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Anthony J. Murgo, MD NCI - Investigational Drug Branch
  More Information

ClinicalTrials.gov Identifier: NCT00003837     History of Changes
Other Study ID Numbers: CDR0000066994
CTEP-TRC-9701
CWRU-TRC-1499
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: June 20, 2013
Last Verified: December 2005

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