Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect 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). 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.

Gender

ALL

Eligibility 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.