Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
16 Years
N/A
Both
Leukemia, Lymphoma
Trial Information
Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
Safety Issue:
No
Principal Investigator
Anthony J. Murgo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Investigational Drug Branch
Authority:
United States: Federal Government
Study ID:
CDR0000066994
NCT ID:
NCT00003837
Start Date:
September 1999
Completion Date:
November 2007
Related Keywords:
- Leukemia
- Lymphoma
- recurrent adult acute lymphoblastic leukemia
- T-cell adult acute lymphoblastic leukemia
- recurrent adult lymphoblastic lymphoma
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| NCI - Pharmaceutical Management Branch | Bethesda, Maryland 20892 |
