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| Descriptive Information Fields | |
| Brief Title † | Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac |
| Official Title † | Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac |
| 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. |
| Study Phase | Phase I |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Leukemia, T-Cell Lymphoma, T-Cell, Cutaneous |
| Intervention † | Drug: Yttrium-90 radiolabeled anti-Tac antibody |
| MEDLINE PMIDs | 2846094, 2785435 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 30 |
| Start Date † | December 1989 |
| Completion Date | October 2000 |
| 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00001249 |
| Organization ID | 900043 |
| Secondary IDs †† | 90-C-0043 |
| Study Sponsor † | National Cancer Institute (NCI) |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | November 1999 |
| First Received Date † | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
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