Clinical Trial DRUG CDX110-04
- An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
- Principal Investigator
- Jeffrey Raizer
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CDX110-04
- The purpose of this research study is to find out whether adding treatment with rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or prevents brain tumors from growing and helps patients with brain tumors live longer than treatment with standard treatment, temozolomide, alone.
- Temozolomide is a standard treatment for glioblastoma, and all patients in this study will be administered temozolomide according to standard treatment. Added to this will be rindopepimut or a "control vaccine" that does not contain rindopepimut. Rindopepimut is a cancer vaccine being investigated to treat glioblastoma by activating the immune system to fight cancer. It is believed that this can be done by “training” the immune system to recognize certain proteins, and causing the immune system to attack and kill tumor cells that contain that protein.
Some of the eligibility criteria include:
- Participants must have newly diagnosed glioblastoma and their tumor must be positive for the EGFRvIII protein.
- Participants must have had attempted surgical removal of their tumor, followed by chemoradiotherapy.
- Participants must be a good candidate for maintenance standard treatment temozolomide therapy.
- Participants must be 18 or older.
- Description of Treatment
- Study participants will be randomly assigned (like flipping a coin) into one of two study groups, and will get either the active, rindopepimut/GM-CSF vaccine or the control vaccine, which does not contain rindopepimut. Participants will get this in addition to standard treatment, temozolomide. Participants will start by receiving two doses of double-blind vaccine (on study days 1 and 15). After these are received, participants will receive temozolomide treatment for 5 days (days 1 – 5) every 28 days. This is called a cycle. Participants will then receive double-blind vaccine on day 22 of each cycle. Treatment with the standard treatment temozolomide will also continue, generally for up to 6 – 12 cycles. Double-blind vaccine injections may continue monthly after finishing the standard treatment, temozolomide, provided there are no serious side effects and the tumor has not grown.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 11-Dec-16 03:59 AM
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