Spots Global Cancer Trial Database for D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

Study Description

Brief Summary: The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).

Detailed Description: Within this study, approximately 50 study participants will receive a single infusion of D2C7-IT in the hospital, which is delivered to the tumor margins over 3 days through a catheter placed in the brain, followed by a single infusion of 2141-V11 delivered over 7 hours to the tumor margins through the same catheter. About 2 weeks after intratumoral infusion of D2C7-IT and 2141-V11, participants will have their first subcutaneous (under the skin) injection of 2141-V11 in the area around the lymph nodes of the head and neck on the same side as the tumor. About a week after this injection, participants will start standard radiation therapy (RT), which typically lasts either 3 weeks or 6 weeks depending upon age. Once RT is finished, participants will resume injections in the area around the lymph nodes of the head and neck on the same side as the tumor of 2141-V11 about 1 week later. They will have another injection about 3 weeks after finishing RT and then start a schedule of injections about every 3 weeks for up to a year. There are risks to the study drugs that are described in this document. Some common risks related to D2C7-IT include: effects related to tumor cells dying (tumor necrosis), effects on normal brain tissue, effects related to catheter placement and removal, effects related to fluid infusion into the brain (intracerebral infusion), and reactions to the D2C7-IT being directly infused in your brain. Risks of 2141-V11 being directly infused in your brain and injected in the area around the lymph nodes of the head and neck could include: cytokine release syndrome (release of immune system cells called cytokines that can cause fever, chills, headache, muscle pain, itching, rash, chest tightness, palpitations, shortness of breath, low blood pressure, nausea, vomiting), swelling and redness in the neck area, overstimulation of your immune system such that it attacks other tissues in your body, elevated liver enzymes, and low platelets in the blood.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial