Study on Maximum Tolerated Dose, Safety, and Effectiveness of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

Sponsor: Plus Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01906385

Provider View

This clinical trial is testing a new treatment called Rhenium Nanoliposomes (186RNL) to see if it is safe and effective for patients with recurrent or worsening malignant glioma, a type of brain cancer, after standard treatments have been tried.

Patient Parameters

Program Overview

This study involves giving a new treatment, 186RNL, directly to the brain tumor using a special delivery method called convection enhanced delivery. The study will start with small doses and gradually increase to find the safest and most effective dose. The goal is to see how well the treatment spreads in the brain and how it affects the tumor. The study will first test different doses to find the maximum tolerated dose (MTD) and then expand to see how effective it is. The starting dose is 1mCi in a volume of 0.660mL.

Description

The study is divided into two phases. In Phase I, a single dose of the study drug 186RNL is given to patients with recurrent glioma through a special catheter. The study will test different dose levels, with 3 to 6 patients at each level, to find the safest dose. Up to 21 patients may participate in this phase. Patients will be monitored for up to 36 months after receiving the treatment.

In Phase II, the study will use a dose found to be safe in Phase I to treat more patients. This phase will include up to 34 patients and will also involve monitoring for up to 36 months after treatment.

The U.S. Food and Drug Administration (FDA) has not yet approved 186RNL for treating this specific type of brain cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Able to understand the study and sign a consent form.
  • Have a confirmed diagnosis of Grade III/IV recurrent glioma.
  • Cancer must have progressed after standard treatments like surgery, chemotherapy, or radiation.
  • If taking seizure medication, must have a stable dose for two weeks without seizures.
  • If taking steroids for brain swelling, must have a stable or decreasing dose for two weeks without worsening symptoms.
  • Tumor must be within the treatment area.
  • Must be in good general health with a performance status score of 0 to 2.
  • Life expectancy of at least 2 months.
  • Must have acceptable liver and kidney function based on blood tests.
  • Must have acceptable blood cell counts.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.

Exclusion Criteria

  • Evidence of recent brain bleeding on scans.
  • Unable to have an MRI scan.
  • Not recovered from side effects of previous cancer treatments.
  • Pregnant or breastfeeding.
  • Serious health conditions that could affect safety or study results, like uncontrolled high blood pressure or heart problems.
  • Other active cancers, except for certain skin or cervical cancers.
  • History of bleeding disorders.
  • Previous treatment with certain cancer therapies like Bevacizumab or specific types of radiation.
  • Tumor spread to multiple areas or the brain lining.
  • Mental health or social issues that could affect participation.
  • Tumor too close to brain ventricles, posing a risk for treatment.
  • For Phase II, tumor volume must be 20 cm3 or less.

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