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

Primary Purpose

Leukemia, T-Cell, Lymphoma, T-Cell, Cutaneous

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yttrium-90 radiolabeled anti-Tac antibody
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, T-Cell focused on measuring Interleukin-2 Receptor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001249
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
December 1989 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, T-Cell, Lymphoma, T-Cell, Cutaneous
Keywords
Interleukin-2 Receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Yttrium-90 radiolabeled anti-Tac antibody

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2846094
Citation
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.
Results Reference
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PubMed Identifier
2785435
Citation
Kozak RW, Raubitschek A, Mirzadeh S, Brechbiel MW, Junghans RP, Gansow OA, Waldmann TA. 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. Erratum In: Cancer Res 1999 Oct 15;59(20):5400. Junghaus R [corrected to Junghans RP].
Results Reference
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Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac

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