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

Exclusion Criteria

• •1. The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
• •2. The subject has contraindications to CNS Magnetic Resonance Imaging (MRI).
• •3. The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for any prior Adverse Events (CTCAE) v4.0 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study.
• •4. The subject is pregnant or breast-feeding.
• •5. The subject has serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety include:
• •1. Uncontrolled hypertension (two or more blood pressure readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment
• •2. non-healing wound, ulcer, or bone fracture
• •3. clinically significant cardiac arrhythmias affecting cardiac function
• •4. untreated hypothyroidism
• •5. uncontrolled systemic infection
• •6. symptomatic congestive heart failure or unstable, untreated angina pectoris within 3 months prior study drug
• •7. myocardial infarction, stroke, transient ischemic attack within 6 months
• •8. known active malignancy (other than glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix
• •6. The subject has an inherited bleeding diathesis or coagulopathy with the risk of bleeding.
• •7. The subject has received any of the following prior anticancer therapy:
• •1. Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site.
• •2. Other CNS radiation therapy within 12 weeks of screening.
• •3. 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
• •4. Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
• •5. 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
• •6. Prior CNS treatment with carmustine wafers
• •7. Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in the prior 28 days from screening.
• •8. Patient actively enrolled in an ongoing investigational drug or device trial excluding follow-up only in a previously trial.
• •8. Multifocal progression or involvement of the leptomeninges.
• •9. Psychiatric illness/social situations that would limit compliance with the study requirements.
• •10. Infratentorial disease unless Investigator and neurosurgeon agree it is treated disease.