Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
N/A
N/A
Both
Leukemia, T-Cell, Lymphoma, T-Cell, Cutaneous
Trial Information
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
The study purpose is to evaluate the clinical response to multidose administration of
anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing
adult T-cell leukemia (ATL). This study represents an extension of phase I trial (Clinical
Project #90-C-0043, FDA IND #3469) which permitted the administration of 5 mCi, 10 mCi, and
15mCi 90Y-anti-Tac to patients with ATL. We propose to administer 90Y-anti-Tac (10 mCi
doses) to patients with Tac-expressing ATL who are over 18 years of age and who fill the
patient eligibility criteria.
Inclusion Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma
(CTCL).
Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with
anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level
greater than 1,500 U required.
All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.
All forms of ATL eligible, including the "smoldering" type as well as aggressive disease.
No symptomatic CNS disease other than tropical spastic paraparesis.
Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such
patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as
appropriate).
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy:
CTCL must have failed initial chemotherapy.
ATL may or may not have had prior chemotherapy.
At least 4 weeks since prior cytotoxic chemotherapy.
Endocrine Therapy: Not specified.
Radiotherapy: At least 4 weeks since prior radiotherapy.
Surgery: Not specified.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: Not specified.
Life expectancy: Greater than 1 month.
Hematopoietic: WBC at least 3,000, Platelets at least 75,000.
Hepatic: Not specified.
Renal: Not specified.
Other:
No pregnant women.
Negative pregnancy test required of fertile women.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
900043
NCT ID:
NCT00001249
Start Date:
December 1989
Completion Date:
October 2000
Related Keywords:
- Leukemia, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Interleukin-2 Receptor
- Leukemia
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| National Cancer Institute (NCI) | Bethesda, Maryland 20892 |
