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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Interleukin 2 Receptor

ClinConnect 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). 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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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