A Phase I Study of Carboxyamidotriazole Orotate Plus Temozolomide in Patients with Glioblastoma Multiforme and Other Recurrent Malignant Gliomas

Protocol
12-007
Full Title
A Phase I Study of Oral Carboxyamidotriazole Orotate (CTO) Titrated as a Single Agent in Patients with Advanced or Metastatic Solid Tumors and Titrated in Combination Therapy with Temodar® for Patients with Glioblastoma or Other Recurrent Malignant Gliomas or in Combination with Temodar and Radiation Therapy for Patients with Newly Diagnosed Glioblastoma and Malignant Glioma
Phase
I
Purpose

Glioblastoma multiforme is a challenging brain tumor to treat, and often recurs despite therapy. In this study, researchers want to find the highest dose of an investigational drug called carboxyamidotriazole orotate (CTO) that can be given in combination with temozolomide, a standard therapy for gliomas, in patients with glioblastoma multiforme and other recurrent malignant gliomas.

CTO works by targeting key proteins involved in brain tumor growth and by inhibiting the development of blood vessels tumors need to grow and spread. Both CTO and temozolomide are taken orally (by mouth).

Eligibility

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

  • Patients must have glioblastoma multiforme or other recurrent malignant glioma that progressed despite prior treatment that included radiation therapy, with or without chemotherapy.
  • Radiation therapy must have been completed 12 or more weeks before entering the study.
  • Patients must have recovered from the serious side effects of previous therapies before entering the study.
  • 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
Locations
Related Diseases