Recurrent Glioblastoma Multiforme Clinical Trial
Official title:
Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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