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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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001249
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: November 1999
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30
Study Start Date: December 1989
Estimated Study Completion Date: October 2000
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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001249

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001249     History of Changes
Other Study ID Numbers: 900043
90-C-0043
Study First Received: November 3, 1999
Last Updated: March 3, 2008

Keywords provided by National Institutes of Health Clinical Center (CC):
Interleukin-2 Receptor

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, T-Cell
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Antibodies
Daclizumab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 18, 2017