Personalized treatment for metastatic gastrointestinal cancer or recurrent glioblastoma patients in Luxembourg

Pilot Study to Explore the Integrated Personalized Functional Profiling (PFP) for Cancer Patients With Metastatic Gastrointestinal Cancer (mGIC) or Recurrent Glioblastoma (rGBM) in Luxembourg

This study is testing a new way to create personalized treatment plans for people with metastatic gastrointestinal cancer or recurrent glioblastoma by using their own cells to see how they respond to existing approved drugs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Luxembourg Institute of Health (Government)
• Locations: 2 sites (Luxembourg and 1 other locations)
• Trial ID: NCT03997617 on ClinicalTrials.gov

What this trial studies

This study aims to develop a novel approach called Integrated Personalized Functional Profiling (PFP) to screen patient-derived cells with FDA/EMA-approved drugs. By utilizing advanced 3D-culture technologies, the PFP process will generate personalized functional response profiles to recommend tailored treatments for patients with metastatic gastrointestinal cancer or recurrent glioblastoma. The pilot study will assess the feasibility of establishing an effective workflow for this personalized treatment strategy, which will inform future clinical validation efforts.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with recurrent glioblastoma or metastatic gastrointestinal cancer who have previously received cancer treatment.

Not a fit: Patients who are pregnant, planning a pregnancy, breastfeeding, or those without viable tumor material will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with specific types of cancer.

How similar studies have performed: While this approach is innovative, similar studies utilizing personalized functional profiling have shown promise in other cancer types, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Patient with recurrent Glioblastoma (rGBM) or with metastatic gastrointestinal cancer (mGIC), i.e. adenocarcinoma (any grade) of stomach, liver, pancreas, small intestine, colon, rectum
* The patient has received previous cancer treatment for mGIC or rGBM
* Male or female ≥ 18 years
* Life expectancy ≥ 12 weeks
* Histologically or cytologically confirmed diagnosis for mGIC or recurrence of a glioblastoma, WHO grade IV
* For women of childbearing potential, a negative pregnancy test documented prior to the screening visit is required
* Signed Inform Consent Form before any study related procedure

Exclusion Criteria:

* For female patient, being pregnant, planning a pregnancy or breastfeeding
* No fresh and viable tumor material available
* Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection
* Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not allow compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol
* In mGIC arm, patient with non-adenocarcinoma gastrointestinal cancer
* Patient unable to understand and consent himself

Where this trial is running

Luxembourg and 1 other locations

• Centre hospitalier de Luxembourg — Luxembourg, Luxembourg (Recruiting)
• Hôpitaux Robert Schmuan — Luxembourg, Luxembourg (Recruiting)

Study contacts

• Study coordinator: Guy Berchem, MD

Conditions Oncology