MOS: Low & Intermediate Grade Glioma Umbrella Study of Molecular Guided TherapieS – Pilot Study

Not Applicable

Completed

• Conditions: Grade 2 glioma (low grade); Grade 3 glioma (intermediate grade); Cancer - Brain

• Registration Number: ACTRN12620000087954
• Lead Sponsor: HMRC Clinical Trials Centre (CTC), University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-03
• Study Completion: 2021-05-31
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients enrolled[This is defined as the absolute number of patients successfully enrolled for molecular phenotyping over the lifetime of the study];Number of patients that successfully complete molecular profiling[This is the absolute number of patients for whom molecular profiling was successfully completed over the lifetime of the study]