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

Free University of Brussels (ULB)

Status: Enrolling

Conditions: CNS Metastases

Treatments: Other: Brain MRI; Other: Samples collection: Non-CNS Metastatic Tumour Tissue; Other: Samples collection: Serum; Other: Samples collection: CSF; Other: Samples collection: Plasma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04109131

IJB-BS-ODN-006

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

CNS metastases from solid tumours

Other group

Description:

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

Treatment:

Other: Samples collection: Plasma

Other: Samples collection: CSF

Other: Samples collection: Serum

Other: Samples collection: Non-CNS Metastatic Tumour Tissue

Other: Brain MRI