D2C&-IT with 2141-V11 for Brain Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if an experimental combination of drugs (D2C7-IT and 2141-V11) is a safe treatment for brain tumors.

What is the Condition Being Studied?

Brain Tumors

Who Can Participate in the Study?

Adults 18 years of age and older who:
- Are diagnosed with Grade III or IV malignant glioma that has progressed or recurred
- Do not take a high dose of a steroid medicine called Decadron or dexamethasone
- Are not taking any types of medicines that affect your immune system

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have the study drugs (D2C7-IT and 2141-V11) put into the area around your tumor
- Stay in the hospital for approximately 4 days
- Have physical exams
- Give blood samples
- Have MRI scans

You will have regular follow-up visits after you leave the hospital. You will have a return clinic visit 2 weeks, 4 weeks, and 8 weeks after your hospital stay and then every 8 weeks for at least one year.

Study Details

Full Title
A Phase 1 Trial of D2C7-IT in Combination with an Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) Administered Intratumorally via Convection-Enhanced Delivery for Adult Patients with Recurrent Malignant Glioma
Principal Investigator
Neuro-oncologist
Protocol Number
IRB: PRO00104852
NCT: NCT04547777
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698