None listed
Conditions
Brief summary
This study aims to evaluate a new approach to provide a ‘personalised’ treatment management plan for patients with glioma that has started to grow again following treatment with radiotherapy and chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or older, with histological confirmed grade 2 or 3 glioma at initial diagnosis. In addition, evidence of progressive disease as defined as evidence of new contrast-enhancing tumour and/or 25% increase in the size of the T2/FLAIR area compared to prior imaging after prior treatment with radiotherapy and chemotherapy. Study details For each participant, the study will involve a taking a sample of tumour tissue during surgery and then screened for a range of biomarkers. If a suitable biomarker is found, the study team will try and match the identified biomarker with specific treatment. Blood samples and imaging assessments will also be obtained during this study. It is hoped that screening tumour tissue for specific biomarkers can inform a personalised treatment plan for patients with brain cancer and provide valuable insight to the feasibility of conducting such trials.
Interventions
Patients will undergo molecular testing using a standardised molecular panel (Illumina TruSight 170 panel) to identify mutations for treatment with matched targeted agents where available or treatment with standard of care therapies. Treatments provided to the patient will be at the discretion of the treating physician and monitored for their efficacy. Patients will be reviewed and assessed 8 weekly until disease progression or 2 years after registration to the study. Blood tests and imaging ass
Patients will undergo molecular testing using a standardised molecular panel (Illumina TruSight 170 panel) to identify mutations for treatment with matched targeted agents where available or treatment with standard of care therapies. Treatments provided to the patient will be at the discretion of the treating physician and monitored for their efficacy. Patients will be reviewed and assessed 8 weekly until disease progression or 2 years after registration to the study. Blood tests and imaging assessments will be collected during the study.
Sponsors
NHMRC Clinical Trials Centre (CTC), University of Sydney
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults, aged 18 years and older, with histological confirmed grade 2 or 3 glioma at initial diagnosis. 2. Prior to last craniotomy and surgery, evidence of progressive disease as defined as evidence of new contrast-enhancing tumour and/or 25% increase in the size of the T2/FLAIR area compared to prior imaging after prior treatment with radiotherapy and chemotherapy. 3. Has available tissue from resection for progressive disease for molecular profiling either within 6 months of study enrolment or following enrolment. 4. For patients who are undergoing standard of care surgery at the time of study entry: a. The patient must be suitable for craniotomy as the opinion of the neurosurgical team who will perform the surgery. b. In the opinion of the neurosurgical team, it will be possible to safely undertake a debulking procedure and that sufficient tissue will be obtained for molecular testing c. Has substantially recovered from their surgical resection, as evidenced by having no major on-going safety issues (e.g. infection requiring antibiotics) 5. Patients who have already undergone standard of care surgery less than or equal to 6 months prior to study registration, there must be sufficient tissue available for molecular testing and the patient must not have had intervening anti-cancer therapy. 6. Dose at registration must be less than or equal to 20mg prednisolone or less than or equal to 3 mg dexamethasone daily (or equivalent). Patients who are not on steroids are preferred for study participation. 7. ECOG performance status 0-2. 8. Has measurable disease post their last craniotomy that is suitable for repeat assessment by MRI scans. 9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 10. Signed, written informed consent (main study and tissue banking).
Exclusion criteria
1. Glioma tissue for molecular pathology obtained greater than or equal to 6 months prior to study entry 2. Any intervening systemic therapy or radiotherapy between most recent imaging showing progressive disease and study enrolment 3. Patients who have had intra-surgical treatments (e.g. oncolytic virus administration, Gliadel wafers) at their last craniotomy prior to study enrolment 4. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. 5. Subjects unable (e.g. due to pacemaker or ICD device) or unwilling to have a contrast-enhanced MRI of the head. 6. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Outcome results
None listed