Leukemia, T-Cell, Lymphoma, T-Cell, Cutaneous
Conditions
Keywords
Interleukin-2 Receptor
Brief summary
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).
Detailed description
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.
Interventions
DRUGYttrium-90 radiolabeled anti-Tac antibody
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed