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Rhenium Nanoliposomes for Recurrent Glioma (ReSPECT)

This study is testing a treatment called Rhenium Liposome Treatment (186RNL) for people with recurrent glioma, a type of brain tumor. The treatment involves placing a catheter (a thin tube) into the tumor during a biopsy, and then infusing 186RNL directly into the tumor. Researchers want to find the highest safe dose of 186RNL (Phase 1) and then see how well it helps people live longer (Phase 2). You may be able to join if you are at least 18 years old and have a confirmed diagnosis of recurrent Grade III/IV glioma. The study is currently unclear about its recruitment status, but plans to enroll up to 55 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves two phases: Phase 1 will enroll up to 21 participants to find the maximum tolerated dose, and Phase 2 will enroll up to 34 participants to evaluate its effectiveness.
What's involved
You would undergo a stereotactic biopsy to place a catheter in your tumor, followed by a single infusion of 186RNL. You will then be followed for up to 36 months after the treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 36 months after receiving the study treatment.

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NCT01906385

Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Plus Therapeutics
~55 participants
Updated 2025-03-26 on ClinicalTrials.gov
What's tested:Rhenium Liposome Treatment

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Maximum Tolerated Dose
Measured over 90 days
+1 more outcome measured

Conditions

Glioma

Explore related trials

Glioma

Where it's being run

3 sites across 2 states
Texas2
New York1

Study leadership

  • Andrew J Brenner, PhD · PRINCIPAL_INVESTIGATOR · The Cancer Therapy and Research Center at UTHSCSA

Who to contact

Rachael Hershey
[email protected]
1(210) 791-8723
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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
known active malignancy (other than glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix unless PI determines it would not impact patient safety or efficacy determinations 6. The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding. 7. The subject has received any of the following prior anticancer therapy:
Prior treatment with Bevacizumab
Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site
Radiation therapy within 12 weeks of screening
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 to study start (dosing)
Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to study start (dosing)
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 study start (dosing)
Prior treatment with carmustine wafers
Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in 28 days prior to study start (dosing) 8. Multifocal progression or involvement of the leptomeninges. 9. Psychiatric illness/social situations that would limit compliance with the study requirements 10. Infratentorial disease 11. The subject has a tumor located within 1-2 cm of a ventricle AND it is determined by the surgeon, PI, and sponsor to be a risk for drug extravasation to the subarachnoid space if given catheter placement and drug administration. 12. Phase 2 only: The subject should have a tumor volume of ≤20 cm3 to be included in the Phase 2 portion of the study. Subjects with tumor volumes of greater than 20 cm3 are excluded from the Phase 2 portion of the study.

What this trial measures

  • Phase 1: Maximum Tolerated Dose90 days

    Evaluation of any toxicity associated with research treatment per Common Toxicity Criteria for Adverse Events.

  • Phase 2: Overall Survival12 Months

    To assess overall survival (OS) following 186RNL administration by convection enhanced delivery (CED) in patients with recurrent glioma.