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

• ClinicalTrials.gov Identifier: NCT00003837
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: June 20, 2013
• Sponsor: National Cancer Institute (NCI)
• Information provided by: National Cancer Institute (NCI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Leukemia; Lymphoma	Drug: nelarabine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Primary Purpose: Treatment
• Official Title: Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
• Study Start Date: September 1999
• Actual Study Completion Date: November 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. Toxicity
2. Antitumor efficacy as defined by the rate of complete hematologic responses

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• 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

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
• Other Study ID Numbers: CDR0000066994; CTEP-TRC-9701; CWRU-TRC-1499
• 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; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid