RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer. PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.
OBJECTIVES: Primary * To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM * To characterize the biodistribution and radiation dosimetry of Cotara® OUTLINE: This is an open-label, dose escalation study of Cotara®. All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.
Barrow Neurological Institute
Phoenix, Arizona, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution
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