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NCT01906385 · ClinicalTrials.gov registry record · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
A Phase 1 study of Glioma, sponsored by Plus Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 3
- Study locations
NCT01906385: Recruiting Phase 1 study of Glioma, sponsored by Plus Therapeutics.
NCT01906385 is a Phase 1 study of Glioma that is actively recruiting participants, run by Plus Therapeutics. The registered enrollment target is 55 participants, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01906385, a Phase 1 study of Glioma, is actively recruiting participants, sponsored by Plus Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Evaluation of any toxicity associated with research treatment per Common Toxicity Criteria for Adverse Events.
Conditions Studied
Interventions
- DRUG Rhenium Liposome Treatment
Study Locations (3)
Texas
- UT Southwestern Medical Center - Dallas
- The Cancer Therapy and Research Center at UTHSCSA - San Antonio
New York
- Northshore University Hospital - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-06-03 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What NCT01906385 shows while recruiting
NCT01906385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which Rhenium Liposome Treatment is the first listed.
NCT01906385 reports a single indexed study location in Texas, New York.
Frequently Asked Questions
What is clinical trial NCT01906385 about?
NCT01906385 is a clinical study titled "Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)". 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 tre...
What is the current status of trial NCT01906385?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2015-06-03. Estimated completion is 2025-12.
What conditions does trial NCT01906385 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT01906385?
The interventions under investigation include: Rhenium Liposome Treatment (DRUG).
Who is sponsoring clinical trial NCT01906385?
This trial is sponsored by Plus Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01906385 being conducted?
This trial has 3 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01906385's enrollment target sits among peer trials
55 34th of 87 higher than 52 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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