Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma

ConditionsRecurrent Glioblastoma IDH Wildtype Recurrent Glioblastoma

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorOlivia Newton-John Cancer Research Institute

About this trial

This study is testing a new way of treating brain tumours using tiny radioactive beads called SIR-Spheres® (90Y-labelled Resin Microspheres). These microspheres are placed into the blood vessels that feed the tumour. The treatment gives off radiation inside the tumour to try to stop it from growing.

This type of treatment is called Selective Internal Radiation Therapy (SIRT), Transarterial Radioembolisation (TARE), or radioembolisation. It is already an accepted treatment for patients with liver cancer. In this study, we are testing if this treatment can be done safely in the brain and how well it works.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years at the time of screening

Histomolecular diagnosis of IDH-wildtype glioblastoma (as per WHO 2021)

Prior treatment with radiotherapy and an alkylating agent

Presence of measurable disease on brain MRI, as defined by RANO 2.0 criteria

Disqualifiers

Multifocal glioma recurrence

Tumour located in the posterior fossa or involving/risking critical subcortical structures (e.g. thalamus, hypothalamus, basal ganglia, internal capsule, cerebral peduncle, midbrain, brainstem, or optic pathways)

Prior treatment with VEGF inhibitors

Prior re-irradiation for progressive or recurrent disease

Trial design

Design model

Single group

Treatments tested in this trial

SIR-Spheres®
Device
Single administration of SIR-Spheres® on Day 1 with optional one-time retreatment if clinically indicated

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety - Treatment-related adverse events

Rate of any treatment-related adverse events within the first 30 days after TARE, according to CTCAE, version 6.0.

Time frame

From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.

Safety - Severe treatment-related adverse events

Rate of any severe treatment-related adverse events (grade ≥3-5) within the first 30 days after TARE, according to CTCAE version 6.0

Time frame

From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.

30-day mortality

Rate of all-cause mortality within 30 days following TARE.

Time frame

From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.

Secondary outcomes

Technical success of TARE

Technical success rate, defined as successful selective catheterisation and administration of SIR-Spheres® to the target volume without significant non-target deposition.

Time frame

6 months after the last patient has been enrolled

Confirmation of dose delivery

Confirmation of dose delivery to the target volume as assessed by post-treatment PET/CT.

Time frame

6 months after the last patient has been enrolled.

Objective response rate (ORR)

Objective response rate (ORR) according to RANO 2.0 and PET RANO 1.0 criteria.

Time frame

6 months after the last patient has been enrolled

Disease control rate (DCR)

Disease control rate (DCR) according to RANO 2.0 and PET RANO 1.0 criteria.

Time frame

6 months after the last patient has been enrolled

Other outcomes

To evaluate the correlation between organ at risk radiation dosimetry and adverse events

Correlation between absorbed dose (Gy) to normal brain, as estimated on post-treatment 90Y PET, and the incidence of treatment-related adverse events, as classified by CTCAE version 6.0

Time frame

6 months after the last patient has been enrolled

To evaluate the concordance between pre-treatment predicted and post-treatment delivered absorbed dose distributions to tumour and normal brain using voxel-based dosimetry

Correlation between absorbed dose estimates to tumour and normal brain derived from pre-treatment \[99mTc\]Tc-MAA SPECT/CT and post-treatment 90Y PET dosimetry

Time frame

6 months after the last patient has been enrolled

To investigate circulating biomarkers and potential mechanisms of resistance, for patients treated with this approach.

Change in circulating biomarker levels from baseline over time, including the identification of molecular or cellular markers associated with treatment response or resistance.

Time frame

6 months after the last patient has been enrolled

Sponsors and contacts

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

Olivia Newton-John Cancer Research Institute

Lead sponsor

Austin Health

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: