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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Plus Therapeutics
Study ID
NCT05460507
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Retreatment Rhenium Liposome — DRUG
    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.

Study Details

This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL.

Key Dates

Start date
Dec 12, 2024
Status verified
Mar 2025
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Retreatment with Rhenium Liposome
    Each participant will receive a single administration of 186RNL. The proposed dose is up to 8.8 mL as a single administration with an administered dose of 22.3 mCi.

Primary Outcome Measure

Assessment of safety and tolerability of a second dose of 186RNL by CED as part of standard of care >30 days following first dose. [ Time Frame: > 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Cancer Therapy and Research Center at UTHSCSASan AntonioTexas78229
Leticia Velten, RN
[email protected]
210-450-1921
Andrew J Brenner, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Antonio, TX

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
The Cancer Therapy and Research Center at UTHSCSA· San Antonio, TX

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