Radiolabeled Monoclonal Antibody Therapy in Treating Adult Patients Who Have Recurrent Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma



Status:Archived
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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Phase I/II of Tac-Expressing Malignancies [Other Than ATL] With Yttrium-90 (90-Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA


RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
cancer-killing substances to them without harming normal cells.

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.


OBJECTIVES:

- 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.


We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute (NCI) The National Cancer Institute (NCI) is part of the National Institutes...
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from
Bethesda, MD
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