D2C7 for Adult Patients With Recurrent Malignant Glioma
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase I study to determine the maximum tolerated dose (MTD) and/or recommended
phase II dose of D2C7-IT (D2C7 Immunotoxin) when delivered intratumorally by
convection-enhanced delivery (CED) to recurrent World Health Organization (WHO) grade III and
IV malignant glioma patients, and/or to determine what dose will be considered in a Phase II
trial. Patients with recurrent WHO grade III and IV malignant glioma who meet eligibility
criteria will be enrolled into the study. Immediately following the stereotactically-guided
tumor biopsy conducted as standard of care, up to three additional core biopsies will be
obtained for molecular genetic testing. After these biopsies are obtained, subjects will have
up to 2 catheters inserted. If the biopsy indicates a proven diagnosis of recurrent malignant
glioma (diagnosis results are typically received within 24-48 hours following biopsy), the
investigators will proceed with the D2C7-IT infusion. If no tumor is identified, the
catheters will be removed. A continuous intratumoral infusion of D2C7-IT will be administered
over 72 hours while in the hospital.