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

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).

Study Overview

• Status: Completed
• Conditions: Lymphoma, T-Cell, Cutaneous; Leukemia, T-Cell
• Intervention / Treatment: Drug: Yttrium-90 radiolabeled anti-Tac antibody

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 Type: Interventional
• Enrollment: 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Cancer Institute (NCI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Publications and helpful links

General 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. 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].

Study record dates

Study Major Dates

• Study Start: December 1, 1989
• Study Completion: October 1, 2000

Study Registration Dates

• First Submitted: November 3, 1999
• First Submitted That Met QC Criteria: December 9, 2002
• First Posted (Estimate): December 10, 2002

Study Record Updates

• Last Update Posted (Estimate): March 4, 2008
• Last Update Submitted That Met QC Criteria: March 3, 2008
• Last Verified: November 1, 1999

More Information

Terms related to this study

• Keywords: Interleukin-2 Receptor
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Lymphoma; Leukemia; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 900043; 90-C-0043