Phase I/II Study of Tac-Expressing Malignancies Other Than Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Humanized Anti-Tac and Calcium-DTPA
Background:
CD25 is expressed on the malignant cells of patients with certain lymphoid malignancies as
well as the non-malignant T cells that surround the malignant tumor cells of patients with
Hodgkin's disease.
Zenapax is a humanized monoclonal antibody that binds to CD25.
Zenapax has been chemically modified by the addition of a chelating molecule to permit
binding of radioactive yttrium.
The yttrium labeled Zenapax binds to CD25 to deliver radiation treatment to the tumor.
Objective:
To assess the toxicity and therapeutic efficacy of (90)Yttrium-labeled humanized
anti-Tac((90)Y-HAT) in patients with Tac-expressing hematologic malignancies.
To determine the sites of localization of radiolabeled Zenapax.
Eligibility:
Patients with Hodgkin's disease and other CD25 positive lymphoid malignancies.
The patient must have a granulocyte of at least 1,200/mm(3) and a platelet count of greater
than 100,000/mm(3).
Design:
Patients will be treated with 10 mCi (if a bone marrow transplant was part of the patient's
previous therapy) or 15 mCi of yttrium labeled Zenapax.
Indium labeled Zenapax is given to demonstrate the antibody distribution and confirm
localization at sites of tumor.
Treatment is given every six weeks if tolerated and patients will be hospitalized for about
one week for each treatment.
Tumor response will be evaluated after every treatment. Stable or responding patients will
continue treatment with evaluations after every cycle of treatment. Patients will be treated
for up to seven cycles.
Interventional
Primary Purpose: Treatment
Thomas A Waldmann, M.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
970110
NCT00001575
April 1997
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |