Clinical trial NCT04109131: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours
Official title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CNS Metastases
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
Collaborators: name: La Fondation contre le cancer, Belgique
name: Les Amis de l'Institut Bordet
name: Bristol-Myers Squibb
name: Fondation Cancer, Luxembourg
First posted: 2019-09-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Better understanding of the epidemiology of CNS metastases from solid tumours
timeFrame: through study completion, approximately 96 months
measure: Better understanding of the epidemiology of CNS metastases from solid tumours
timeFrame: through study completion, approximately 96 months
measure: Better understanding of the epidemiology of CNS metastases from solid tumours
timeFrame: through study completion, approximately 96 months
measure: Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
timeFrame: through study completion, approximately 96 months
measure: Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
timeFrame: through study completion, approximately 96 months
measure: Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
timeFrame: through study completion, approximately 96 months
measure: Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
timeFrame: through study completion, approximately 96 months
measure: Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
timeFrame: through study completion, approximately 96 months
measure: Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
timeFrame: through study completion, approximately 96 months
Secondary outcomes:
Other outcomes:
measure: Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.
timeFrame: through study completion, approximately 96 months
measure: Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.
timeFrame: through study completion, approximately 96 months
measure: Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.
timeFrame: through study completion, approximately 96 months
Locations:
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Namur
country: Belgium
facility: CHU UCL Namur - Site de Sainte-Elisabeth
city: Lille
country: France
facility: Centre Oscar Lambret
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Paris
country: France
facility: Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon
city: Paris
country: France
facility: Institut Curie
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Institut Universitaire du Cancer - Oncopole
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
Study officials:
affiliation: Jules Bordet Institute
name: Nuria Kotecki, MD
role: STUDY_CHAIR
References: