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
Darell Bigner
Summary
The purpose of this study is to assess the safety and efficacy of the combination of D2C7-IT+2141-V11 administered in the non-enhancing tumor of patients with resected recurrent glioblastoma (rGBM) via convection enhanced delivery (CED), followed by subcutaneous cervical perilymphatic injections (CPLIs) of 2141-V11 2 and 4 weeks post infusion, then every 3 weeks for a year, and every 4-6 weeks thereafter if patients benefit from therapy.
Description
Approximately 46 evaluable patients will be enrolled in this study. Enrolled patients must have previously undergone maximal safe surgical tumor resection, with histopathologic confirmation of recurrence of GBM. Post-operative MRI also must have demonstrated a residual area of non-enhancing disease (as assessed by T2/ FLAIR images) that is amenable to infusion (no larger than 3 x 3 cm of residual enhancing disease). Study participants will receive D2C7-IT and 2141-V11 infused in the residual disease via CED followed by repeated, imaging guided injections of 2141-V11 in the cervical perilympha…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years old at the time of entry into the study 2. Histopathologically confirmed WHO grade 4 IDHwt GBM (high grade glioma with molecular features of glioblastoma will be eligible) 3. Karnofsky Performance Score (KPS) ≥ 70% 4. Hemoglobin ≥ 9 g/dl prior to biopsy 5. Platelet count ≥ 100,000/µl unsupported is necessary for eligibility on the study; however, because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000/µl is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platel…
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