Delivery of D2C7-IT and 2141-V11 Combination Immunotherapy in Residual Disease for Adult Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma and Perilymphatic Subcutaneous Injections of 2141-V11
Darell Bigner
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).
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, parti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years of age at the time of entry into the study 2. Newly diagnosed supratentorial GBM, WHO grade 4, IDH wildtype, MGMT unmethylated (high grade glioma with molecular features of GBM will be eligible under WHO 4 malignant glioma) with residual radiographic non-contrast enhancing disease on the post-2 cycles of adjuvant TMZ MRI amenable to catheter placement. The residual radiographic contrast enhancing disease is ≤ 3 cm in maximal diameter in any plane. 3. Patient must have completed standard of care radiation therapy (typically 59.4-60 Gy over approximately 6…
Interventions
- DrugD2C7-IT
D2C7-IT will be dosed at 166,075 ng in 36 mL.
- Drug2141-V11
2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.
Location
- Duke University Medical CenterDurham, North Carolina