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

ConditionGlioma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPlus Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 Committee.

Histologically confirmed Grade III/IV recurrent Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4; Glioblastoma, IDH-wildtype grade 4).

Progression by RANO criteria or other clinically accepted neurooncology evaluation, following standard treatment options with known survival benefit for any recurrence (e.g., surgery, temozolomide, radiation, and tumor treating fields). Patient may be included in study if medically unable or unwilling to follow standard treatment options for any recurrence.

Disqualifiers

The subject has evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.

The subject is unable or contraindicated to undergo MRI scan (e.g., has pacemaker or medically unstable).

The subject has not recovered to CTCAE v4.0 Grade ≤1 from AEs (except alopecia, anemia, and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study.

The subject is pregnant or breast-feeding.

Trial design

Design model

Single group

Treatments tested in this trial

  • Rhenium Liposome Treatment

    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.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: 186Rhenium Liposome TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Maximum Tolerated Dose

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

Time frame
90 days
2

Phase 2: Overall Survival

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

Time frame
12 Months

Secondary outcomes

1

Phase 1: Dose Distribution

SPECT imaging of the radioactive materials spread across the tumor and surrounding brain

Time frame
Up to 7 days
2

Phase 1: Response rate

Evaluation of overall response rate by RANO criteria

Time frame
8 weeks followed by standard of care
3

Phase 1: Survival

Disease specific progression free survival

Time frame
6 months
4

Phase 1: Safety of single dose of treatment

Evaluation of any toxicity associated with research treatment as determined by the most recent version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Plus Therapeutics

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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