Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma

Required: MGMT promoter methylation

If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial

Allowed: MGMT promoter methylation

If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial

Must have received: chemotherapy

patients must have received at least one chemotherapy regimen prior to participating in this trial (if MGMT promoter methylated or unknown)

Must have received: surgical procedure

Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy

Must have received: radiation therapy

Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy

Cannot have received: chemotherapy

Exception: nitrosourea (6 weeks), metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)

Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from side effects of such therapy

Cannot have received: bevacizumab (bevacizumab)

Exception: see above

Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from side effects of such therapy

Cannot have received: immunotherapy

Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy

Cannot have received: tumor treating fields (Optune)

Patients may not have received treatment with tumor treating fields (e.g., Optune) ≤ 1 week prior to starting the study drug

Cannot have received: radiation therapy

Exception: unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation

Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation