Purpose of this Study
To join this study, you must have already had surgery to remove as much of your tumor as possible. Once you are in the study, you will have another surgery to take a tiny piece of tissue and place a thin tube called a catheter in your brain where the tumor is. Through this tube, you will get a medicine called D2C7-IT for three days. Then you will get another medicine called 2141-V11 for about seven hours.
About two weeks later, you will start getting shots of 2141-V11 under your skin near the lymph nodes in your head and neck. You will get another shot two weeks after that, and then shots every four weeks for up to a year. After that, you may keep getting shots every 4 to 6 weeks if you want.
Who Can Participate?
Eligibility
To join this study, you must be at least 18 years old and have a certain type of brain cancer called glioblastoma. You need to have had surgery to remove the tumor 3 to 5 weeks before getting the study medicine, and doctors must confirm the tumor came back. You also need to be healthy enough to take part, with a score called KPS of 70 or higher.
You cannot join if you are pregnant or breastfeeding, have very serious health problems, infections, or certain diseases like HIV. You also cannot join if you recently had chemotherapy or immunotherapy and have not recovered from side effects.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to find out if giving two medicines, D2C7-IT and 2141-V11, directly into the part of the brain where the tumor is left after surgery is safe and works well. After that, patients will get regular shots of 2141-V11 under the skin near the lymph nodes in the head and neck. This study is for people who have a brain cancer called recurrent glioblastoma.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Phase 1b Clinical Trial of D2C7-IT + 2141-V11 combination immunotherapy administered via convection enhanced delivery in non-enhancing tumor post-resection of recurrent glioblastoma, followed by cervical perilymphatic subcutaneous injections of 2141-V11
Principal Investigator
Annick
Desjardins
Protocol Number
PRO00115800
NCT ID
NCT06455605
Phase
I
Enrollment Status
Open to Enrollment