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 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.

Trial Details

NCT ID
NCT01906385
Phase
PHASE1 / PHASE2
Sponsor
Plus Therapeutics
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Rhenium Liposome Treatment
Locations (sample)
  • Manhasset, New York, United States|40.79788,-73.69957
  • Dallas, Texas, United States|32.78306,-96.80667
  • San Antonio, Texas, United States|29.42412,-98.49363

Key Eligibility Criteria

  • At least 18 years of age.
  • Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics …
  • Histologically confirmed Grade III/IV recurrent Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4; Gl…
  • Progression by RANO criteria or other clinically accepted neurooncology evaluation, following standard treatment options with known survival benefi…

For full eligibility, visit ClinicalTrials.gov.

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