506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
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.
|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|
- Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Antitumor efficacy as defined by the rate of complete hematologic responses [ Designated as safety issue: No ]
|Study Start Date:||September 1999|
|Study Completion Date:||November 2007|
- 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.
|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|
|Study Chair:||Anthony J. Murgo, MD||NCI - Investigational Drug Branch|