CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 55 target
Drug / intervention
Rhenium Liposome Treatmentdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed Grade III/IV recurrent Glioma following 2021 WHO CNS5 nomenclature
  • ✓Progression by RANO criteria following standard treatment options
  • ✓At least 18 years of age
  • ✓Life expectancy of at least 2 months
Key exclusion· 15
  • ✕Evidence of acute intracranial or intratumoral hemorrhage
  • ✕Unable or contraindicated to undergo MRI scan
  • ✕Not recovered to CTCAE Grade ≤1 from adverse events due to prior antineoplastic agents
  • ✕Pregnant or breast-feeding

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01906385
NCT01906385Phase 2RecruitingUpdate OverdueUpdated 15mo ago · Completion was 7mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)

Plus Therapeutics·interventional·Posted Jul 24, 2013·Updated Mar 26, 2025

In Brief

A Phase 2 clinical trial evaluating Rhenium Liposome Treatment for Glioma. Currently recruiting, targeting 55 participants across 3 sites.

Signals

Enrollment appears stalled

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2RecruitingOverdue
2014201520162017201820192020202120222023202420252026
First PostedJul 24, 2013
Enrollment StartJun 3, 2015
Primary CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 12.9 years ago

Interventions

Rhenium Liposome Treatmentdrug

At the time of stereotactic biopsy a catheter will be placed within the tumor using stereotactic guidance. Once the patient has adequately recovered from the procedure as determined by the neurosurgeon, 186RNL will be infused through the CED catheter at the predetermined dose. Spectroscopic imaging will then be obtained at predefined time points to visualize the distribution of the 186RNL as well as calculated the actual dose retained within the tumor. Patients will be monitored longitudinally for evidence of toxicity and response by MRI.