D2C7-IT and Atezolizumab in Recurrent Malignant Glioma
What is the Purpose of this Study?
If you choose to join this study, you will:
- Have the study drug (D2C7-IT) put into the area of the tumor that is in your brain
- Stay in the hospital 3-4 days
2 weeks after your hospital stay you will be asked to come to the Duke clinic every 3 weeks (for up to 2 years) where you will have:
- An infusion (into the vein) of Atezolizumab (an immunotherapy)
- A physical exam
- A blood draw
- MRIs at certain visits or as needed
- Have the study drug (D2C7-IT) put into the area of the tumor that is in your brain
- Stay in the hospital 3-4 days
2 weeks after your hospital stay you will be asked to come to the Duke clinic every 3 weeks (for up to 2 years) where you will have:
- An infusion (into the vein) of Atezolizumab (an immunotherapy)
- A physical exam
- A blood draw
- MRIs at certain visits or as needed
What is the Condition Being Studied?
Grade III or IV malignant glioma (brain tumor) that has progressed or recurred
Who Can Participate in this Study?
Adults 18+ who:
- Have been diagnosed with Grade III or IV malignant glioma that has progressed or recurred
- Are not currently taking a high dose of the steroid medicine called Decadron or dexamethasone
- Are not currently being treated with types of medicines that affect your immune system
For more information about who can join this study, please contact the study team at 919-684-5301.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to learn if the study drugs (D2C7-IT) and Atezolizumab can be safely and effectively given to people with malignant gliomas that have progressed or recurred.
Study Details
Full Title
A Phase 1 Trial of D2C7-IT in Combination with Atezolizumab in Recurrent WHO Grade IV Malignant Glioma
Principal Investigator
Protocol Number
IRB:
PRO00101898
NCT:
NCT04160494
ClinicalTrials.gov
View on ClinicalTrials.gov