Study on D2C7-IT and 2141-V11 for Newly Diagnosed Glioblastoma Patients

Program Overview

The purpose of this study is to find out if two investigational drugs, D2C7-IT and 2141-V11, are safe and effective for treating glioblastoma, a type of brain cancer. Participants will receive these drugs directly into the brain after surgery and later under the skin near the lymph nodes in the head and neck. The drugs are still being tested and are not yet approved by the FDA.

Description

In this study, about 50 participants will receive a single dose of D2C7-IT through a catheter placed in the brain, which will be delivered over 3 days. This will be followed by a single dose of 2141-V11 over 7 hours through the same catheter. About 2 weeks later, participants will receive their first injection of 2141-V11 under the skin near the lymph nodes in the head and neck. A week after this injection, participants will start standard radiation therapy, which lasts 3 to 6 weeks depending on age. After radiation therapy, participants will continue receiving injections of 2141-V11 every 3 weeks for up to a year.

There are risks associated with the study drugs. Common risks of D2C7-IT include effects from tumor cells dying, effects on normal brain tissue, and reactions to the drug being infused in the brain. Risks of 2141-V11 include cytokine release syndrome, which can cause symptoms like fever, chills, and shortness of breath, as well as swelling and redness in the neck area, and overstimulation of the immune system.

Eligibility Criteria