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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001249 |
Purpose
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).
| Condition | Intervention | Phase |
|
Leukemia, T-Cell Lymphoma, T-Cell, Cutaneous |
Drug: Yttrium-90 radiolabeled anti-Tac antibody |
Phase I |
| MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
| Drug Information available for: | Interleukin-2 Dacliximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 1989 |
| Estimated Study Completion Date: | October 2000 |
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 900043, 90-C-0043 |
| First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001249 |
| Health Authority: | United States: Federal Government |
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