Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

Allowed: IDH1 mutation

Astrocytoma, IDH-mutant grade 3 or 4

Allowed: IDH2 mutation

Astrocytoma, IDH-mutant grade 3 or 4

Allowed: IDH1 wild-type

Glioblastoma, IDH-wildtype grade 4

Must have received: standard treatment options with known survival benefit (surgery, temozolomide, radiation, tumor treating fields) — any recurrence

Progression by RANO criteria or other clinically accepted neurooncology evaluation, following standard treatment options with known survival benefit for any recurrence (e.g., surgery, temozolomide, radiation, and tumor treating fields). Patient may be included in study if medically unable or unwilling to follow standard treatment options for any recurrence.

Cannot have received: VEGF inhibitor (bevacizumab)

Prior treatment with Bevacizumab

Cannot have received: non-standard radiation therapy (brachytherapy, systemic radioisotope therapy, intra-operative radiotherapy (IORT))

Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site

Cannot have received: radiation therapy

Radiation therapy within 12 weeks of screening

Cannot have received: systemic therapy (investigational agents, small-molecule kinase inhibitors)

Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 14 days or 5 half-lives, whichever is shorter, prior to study start (dosing)

Cannot have received: biologic agent (antibodies, immune modulators, vaccines, cytokines)

Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to study start (dosing)

Cannot have received: alkylating agent (nitrosoureas, mitomycin C)

Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to study start (dosing)

Cannot have received: cytotoxic chemotherapy

other cytotoxic chemotherapy within 28 days, prior to study start (dosing)

Cannot have received: cytotoxic chemotherapy (metronomic/protracted low-dose chemotherapy)

metronomic/protracted low-dose chemotherapy within 14 days, prior to study start (dosing)

Cannot have received: local chemotherapy (carmustine wafers)

Prior treatment with carmustine wafers

Cannot have received: investigational agent

Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in 28 days prior to study start (dosing)