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

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	December 1989
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Leukemia, T-Cell Lymphoma, T-Cell, Cutaneous
Intervention ^ICMJE	Drug: Yttrium-90 radiolabeled anti-Tac antibody
Study Arms / Comparison Groups
Publications *	Waldmann TA, Goldman CK, Bongiovanni KF, Sharrow SO, Davey MP, Cease KB, Greenberg SJ, Longo DL. Therapy of patients with human T-cell lymphotrophic virus I-induced adult T-cell leukemia with anti-Tac, a monoclonal antibody to the receptor for interleukin-2. Blood. 1988 Nov;72(5):1805-16. Kozak RW, Raubitschek A, Mirzadeh S, Brechbiel MW, Junghans RP, Gansow OA, Waldmann TA, Junghaus R. Nature of the bifunctional chelating agent used for radioimmunotherapy with yttrium-90 monoclonal antibodies: critical factors in determining in vivo survival and organ toxicity. Cancer Res. 1989 May 15;49(10):2639-44.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	October 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001249
Responsible Party
Study ID Numbers ^ICMJE	900043, 90-C-0043
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	November 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP