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PURPOSE: This phase I/II trial is studying the side effects and best dose of radiolabeled monoclonal antibody when given together with pentetic acid calcium and to see how well they work in treating patients with recurrent Hodgkin's lymphoma or non-Hodgkin's lymphoma.
- Assess the toxicity and therapeutic efficacy of yttrium Y 90 radiolabeled humanized anti-Tac (HAT) monoclonal antibody in patients with Tac expressing hematologic malignancies.
- Define the pharmacokinetics of indium In 111 and yttrium Y 90 HAT monoclonal antibodies.
OUTLINE: This is a dose-escalation study.
Patients are given yttrium Y 90 labeled humanized anti-Tac monoclonal antibody (Y-HAT) according to an escalating dose schedule along with a fixed dose of pentetic acid calcium (Ca-DTPA) and indium In 111 labeled humanized anti-Tac monoclonal antibody (In-HAT). On day 1, Y-HAT and In-HAT are administered IV over 2 hours followed by a 5-hour infusion of Ca-DTPA. Additional 5-hour infusions of Ca-DTPA are given on days 2 and 3. Treatment may repeat every 6 weeks for up to 7 courses.
Cohorts of 3 to 6 patients are enrolled at each dose level. Dose escalation continues until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. After the MTD is defined the phase II portion of the study begins.
PROJECTED ACCRUAL: Approximately 65 patients will be accrued in phase I and an additional 30 patients in phase II.
Primary Purpose: Treatment
daclizumab, pentetic acid calcium
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:56:48-0400
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An iron chelating agent with properties like EDETIC ACID. DTPA has also been used as a chelator for other metals, such as plutonium.
A complex of gadolinium with a chelating agent, diethylenetriamine penta-acetic acid (DTPA see PENTETIC ACID), that is given to enhance the image in cranial and spinal MRIs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p706)
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Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
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