A Phase I Study of TRC105 plus Bevacizumab in Patients with Recurrent Glioma

Protocol
12-217
Full Title
Phase I/Comparative Randomized Phase II Trial of TRC105 Plus Bevacizumab Versus Bevacizumab in Bevacizumab-Naïve Patients With Recurrent Glioblastoma Multiforme (N1174)
Purpose

Bevacizumab is approved for the treatment of a challenging brain tumor called glioma. However, most cases of glioma continue to grow despite this therapy. In this study, researchers want to find the highest dose of an investigational drug called TRC105 that can be given safely with bevacizumab in patients with recurrent glioma.

Bevacizumab works by inhibiting the development of the blood vessels that tumors need to grow and spread. TRC105 also targets tumor blood vessel development, and may help bevacizumab work better against glioma. Both drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a grade 3 or 4 glioma that has returned despite prior therapy.
  • At least 4 weeks must have passed since completion of prior surgery or chemotherapy and 12 weeks since any prior radiation therapy and entry into the study.
  • Patients who had prior hypersensitivity to bevacizumab or who had to stop taking it due to its side effects may not participate.
  • In the first portion of this study, patients in whom bevacizumab is no longer working are also eligible.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Antonio Omuro at 212-639-7523.

Disease(s)
Brain Tumors, Primary
Brain Tumors, Primary: Gliomas
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