Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT) (NCT01906385)
🩺 Plain-English Summary (8th-Grade Level)
This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (28 items).
Location: Northshore University Hospital — Manhasset, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
- The subject is unable or contraindicated to undergo MRI scan (e.g., has pacemaker or medically unstable).
- The subject has not recovered to 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.
- The subject is pregnant or breast-feeding.
- The subject has serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety or study outcomes such as:
- hypertension (two or more blood pressure readings performed at screening of \>150 mmHg systolic or \>100 mmHg diastolic) despite optimal treatment
- active medically significant infection unresponsive to antibiotics (e.g., non- healing wound, ulcer), uncontrolled systemic infection, or bone fracture
- clinically significant cardiac arrhythmias not controlled by appropriate medications
- untreated hypothyroidism
- symptomatic congestive heart failure or unstable angina pectoris within 3 months prior to study drug
- myocardial infarction, stroke, or transient ischemic attack within 6 months prior to study drug
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Northshore University Hospital — Manhasset, New York
- UT Southwestern Medical Center — Dallas, Texas
- The Cancer Therapy and Research Center at UTHSCSA — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.