A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours

Study Purpose

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 18 years old. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 3. Female or Male. 4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3). Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program. Seven cohorts of subjects are defined in this prospective multicenter study:

- Cohort 1: Triple negative breast cancer (TNBC) - Cohort 2: HER 2 positive breast cancer (HER2+ BC) - Cohort 3: Non-small cell lung cancer (NSCLC) - Cohort 4: Small cell lung cancer (SCLC) - Cohort 5: Melanoma.

- Cohort 6: Other solid tumours (apart from the above mentioned subtypes.

- Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis.

5. Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion. 6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications. 7. Predicted life expectancy > 3 months. 8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment. 9. Effective contraception is in place for women of childbearing potential. 10. Completion of all necessary screening procedures within 28 days prior to enrolment. 11. Signed Informed Consent form (ICF) obtained prior to any study related procedure. Inclusion criterion applicable to FRANCE only. 12. Affiliated to the French Social Security System.

Exclusion Criteria:

1. Pregnant and/or lactating women. 2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin. 3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study. Exclusion criterion applicable to FRANCE only. 4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04109131
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jules Bordet Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nuria Kotecki, MD
Principal Investigator Affiliation	Jules Bordet Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Belgium, France, Luxembourg
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	CNS Metastases

Arms & Interventions

Arms

Other: CNS metastases from solid tumours

The study will be organised on three time-periods based on the time of the 1st CNS event: Part A - Pre-diagnosis period: before diagnosis of the 1st CNS event Part B - At 1st CNS diagnosis period Part C - Post diagnosis period: after the 1st CNS event

Interventions

Other: - Samples collection: Plasma

At baseline Part A: TNBC/ HER2+ BC: once a year NSCLC/SCLC: every 4 months Melanoma: every 6 months Part B: o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: o Every 3 months (+/- 1 month)

Other: - Samples collection: CSF

Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice

Other: - Samples collection: Non-CNS Metastatic Tumour Tissue

Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Other: - Brain MRI

Part A: Brain MRI at inclusion is allowed within 45 days before enrolment Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month) Part B: o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)

Other: - Samples collection: Serum

Contact a Trial Team

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International Sites

Institut Jules Bordet, Anderlecht, Belgium

Status

Recruiting

Address

Institut Jules Bordet

Anderlecht, , 1070

Site Contact

Sylvie Bartholomeus

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