Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Prior 186RNL Treatment

Must have received: Rhenium-186 NanoLiposomes (186RNL)

Patient must present with biopsy and histology proven glioma following initial treatment with 186RNL

Must have received: standard treatment (surgery, radiotherapy, and/or chemotherapy)

Patients must have malignant glioma that has progressed on or after standard treatment (surgery, radiotherapy, and/or chemotherapy)

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: CNS radiation therapy

Exception: within 12 weeks of screening

Other CNS radiation therapy within 12 weeks of screening

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

Exception: within 14 days or 5 half-lives, whichever is shorter, prior first dose of study drug

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 first dose of study drug

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

Exception: within 21 days prior to first dose of study drug

Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug

Cannot have received: nitrosoureas (mitomycin C)

Exception: within 42 days prior to first dose of study drug

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 first dose of study drug

Cannot have received: metronomic/protracted low-dose chemotherapy

Exception: within 14 days prior to first dose of study drug

metronomic/protracted low-dose chemotherapy within 14 days

Cannot have received: cytotoxic chemotherapy

Exception: within 28 days prior to first dose of study drug

other cytotoxic chemotherapy within 28 days, prior to first dose of study drug

Cannot have received: CNS treatment with carmustine wafers (carmustine wafers)

Prior CNS treatment with carmustine wafers

Cannot have received: investigational agents

Exception: currently receiving or received in the prior 28 days from screening

Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in the prior 28 days from screening

Cannot have received: investigational drug or device trial

Exception: excluding follow-up only in a previous trial

Patient actively enrolled in an ongoing investigational drug or device trial excluding follow-up only in a previously trial