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

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nelarabine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, recurrent adult lymphoblastic lymphoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • NCI - Pharmaceutical Management Branch
  • Barbara Ann Karmanos Cancer Institute
  • Mayo Clinic Cancer Center
  • Case Comprehensive Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania

Outcomes

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

Full Information

First Posted
November 1, 1999
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003837
Brief Title
506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Official Title
Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, recurrent adult lymphoblastic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nelarabine
Primary Outcome Measure Information:
Title
Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
Secondary Outcome Measure Information:
Title
Toxicity
Title
Antitumor efficacy as defined by the rate of complete hematologic responses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J. Murgo, MD
Organizational Affiliation
NCI - Investigational Drug Branch
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
NCI - Pharmaceutical Management Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5047
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

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

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