← Back to Search

Radiation

Rhenium Liposome Treatment for Brain Cancer

Phase 1 & 2

Recruiting

Led By Andrew J Brenner, MD, PhD

Research Sponsored by Plus Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Histologically confirmed Grade III/IV recurrent Glioma following 2021 WHO CNS5 glioma nomenclature

Must not have

Infratentorial disease

Tumor located within 1-2 cm of a ventricle and determined to be a risk for drug extravasation to the subarachnoid space if given catheter placement and drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment to see if it is safe and effective. It uses a modified Fibonacci dose escalation, which means it starts with a small dose and increases the dose each time until the maximum tolerated dose is reached. The starting absorbed dose is 1mCi in a volume of 0.660mL.

Who is the study for?

Adults with Grade III/IV recurrent glioma who've had standard treatments can join this trial. They must understand the study, not have seizures or recent serious health issues, and agree to use contraception. Excluded are those with MRI contraindications, unresolved side effects from previous treatments, acute bleeding in the brain, other active cancers (except certain skin cancers), or those who've recently received specific cancer therapies.

What is being tested?

The ReSPECT trial is testing Rhenium Liposome Treatment's safety and effectiveness for brain tumors. It involves increasing doses of a radioactive substance delivered directly into the tumor to find the highest dose patients can tolerate without severe side effects before assessing its efficacy.

What are the potential side effects?

Potential side effects may include reactions at the injection site, general discomfort or pain due to treatment administration, possible radiation-related symptoms such as nausea or fatigue, and any unforeseen complications related to direct delivery of a substance into the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My brain tumor is a high-grade glioma that has come back.

Select...

My brain tumor has grown despite treatment.

Select...

I have been on a stable or decreasing dose of steroids for brain swelling for at least two weeks without worsening symptoms.

Select...

My brain tumor is a high-grade glioma within the treatment area.

Select...

I can care for myself and am up more than 50% of my waking hours.

Select...

My kidney function is within normal limits.

Select...

My liver function tests are within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition affects the lower part of my brain.

Select...

My tumor is close to a brain ventricle, posing a risk for drug leakage.

Select...

I still have significant side effects from cancer treatment drugs.

Select...

I have a genetic condition that increases my risk of bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Maximum Tolerated Dose

Phase 2: Overall Survival

Secondary study objectives

Phase 1: Dose Distribution

Phase 1: Response rate

Phase 1: Safety of single dose of treatment

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 186Rhenium Liposome TreatmentExperimental Treatment1 Intervention

Arm Phase I: Experimental: Dose Escalation for Cohorts 1-8 Each participant will receive a single administration of 186RNL. At each dose level, a minimum of three to a maximum of six participants will be enrolled. If no dose limiting toxicity is observed in the initial three participants, then the next higher dose level cohort will open for enrollment. The dose escalation scheme will follow a modified Fibonacci dose escalation scheme as shown below: COHORT ACTIVITY Cohort 1 (1.0 mCi) Cohort 2 (2.0 mCi) Cohort 3 (4.0 mCi) Cohort 4 (8.0 mCi) Cohort 5 (13.4 mCi) Cohort 6 (22.3 mCi) Cohort 7 (31.2 mCi) Cohort 8 (41.5 mCi) Phase 2: Single arm, prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117, NIH-NCI Grant (22.3 mCi (total 186RNL activity) at a concentration of 2.5 mCi/mL and 8.8 mL total volume).

0 / 12Eligibility criteria met