Clinical Trial NU 12C02
- A Phase I-II trial Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas BTTC09-01
- Principal Investigator
- Jeffrey Raizer
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 12C02
- This study has two phases. In Phase I, the purpose of this study is to determine the highest safe dose and best schedule for the combination of the study drugs, everolimus and sorafenib, for malignant glioma. In Phase II, the purpose is to evaluate the effect of these drugs on malignant gliomas.
- Everolimus and sorafenib are both approved by the Federal Drug Administration (FDA) for the treatment of some types of cancers. Everolimus is designed to block a special protein in tumor cells and block the formation of new blood vessels, which is important in tumor growth and is used in the treatment of kidney cancer and some types of brain tumors. Sorafenib is designed to stop cell growth and to block the formation of new blood vessels (the tubes that carry blood around the body), which are involved in the growth and development of tumors and is used in the treatment of kidney cancer. The combination of everolimus and sorafenib to treat this type malignant glioma is investigational.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have recurrent intracranial malignant glioma. (a type of brain cancer)that has come back after prior treatment(it has recurred)
- Participants must not have received more than 2 prior chemotherapies.
- Description of Treatment
- All participants will be assigned to receive a certain dose of both everolimus and sorafenib. Everolimus is taken by mouth once a day. Sorafenib is taken by mouth twice a day. Participants can keep receiving the study drugs as long as their disease is not getting worse, and they are not having side effects that cannot be managed.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase II Study of the Efficacy of Hypofractionated Radiation Therapy with Bevacizumab and Temozolomide Followed by Maintenance Temozolomide and Bevacizumab for Recurrent High-Grade Gliomas
- A Phase II, open label, clinical trial of pre-surgical and adjuvant treatment of recurrent malignant glioma with Tremelimumab and Durvalumab (MEDI4736) alone and in combination to determine immunologic changes from treatment.
last updated: 20-Oct-16 04:18 PM
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