Search / Trial NCT00001249

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of May 26, 2024

Completed

Keywords

Interleukin 2 Receptor

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.

Gender

All

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.

Attachments

readout_NCT00001249_2024-05-26.pdf

4.5 MB

NCT00001249_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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