Clinical Trial NU MD12C01
- Phase I/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus Vorinostat in Adults with Recurrent Glioblastoma (BTTC11-02)
- Principal Investigator
- Jeffrey Raizer
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU MD12C01
- The purpose of this study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.
- Bevacizumab and vorinostat are both approved by the Federal Drug Administration (FDA). Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels and is used as treatment recurrent glioblastoma. Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Vorinostat is used in treatment of some types of lymphoma (a blood cancer). The use of both of these drugs in combination is experimental.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have recurrent (returning) glioblastoma or gliosarcoma (malignant brain tumor).
- Participants must not have had treatment(s) with bevacizumab or vorinostat before.
- Description of Treatment
- This study has two phases. During the first phase, participants will be randomly assigned (like rolling dice) to receive either only bevacizumab or bevacizumab and vorinostat. Bevacizumab is given IV (by vein) on days 1 and 15 of every cycle. One cycle is 28 days. Vorinostat is a capsule that is taken by mouth on days 1-7 and 15-21 of each 28-day cycle. Participants in phase II will be assigned to the group showing the best results in the first phase. Participants may take the study drugs for up to a year and can continue beyond a year if the doctor feels that it is in their best interest.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 26-Sep-16 07:13 AM
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