506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
- Conditions
- LeukemiaLymphoma
- Registration Number
- NCT00003837
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Toxicity Antitumor efficacy as defined by the rate of complete hematologic responses
Trial Locations
- Locations (7)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
NCI - Pharmaceutical Management Branch
🇺🇸Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
City of Hope Comprehensive Cancer Center🇺🇸Duarte, California, United States