Combining two drugs for treating aggressive meningiomas
Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas: Phase 1 Study
PHASE1 · Assistance Publique Hopitaux De Marseille · NCT03631953
This study is testing a combination of two drugs to see if they can help people with aggressive meningiomas that haven't improved with other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Drugs / interventions | Trametinib |
| Locations | 1 site (Marseille) |
| Trial ID | NCT03631953 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combination of Alpelisib, a PI3Kα inhibitor, and Trametinib, a MEK inhibitor, for patients with progressive refractory meningiomas that have not responded to previous treatments. The study aims to assess the safety and efficacy of this drug combination in inducing apoptosis in tumor cells and improving progression-free survival. Patients will undergo MRI scans to monitor tumor growth and will provide blood samples for analysis. The trial is designed for individuals who have exhausted other treatment options and have histologically confirmed meningiomas.
Who should consider this trial
Good fit: Ideal candidates include patients with grade I, II, or III meningiomas who have shown tumor progression after previous surgeries and radiotherapy.
Not a fit: Patients who are currently pregnant, breastfeeding, or have contraindications to Alpelisib and Trametinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with aggressive meningiomas that are resistant to current therapies.
How similar studies have performed: While the combination of these specific drugs in meningiomas is novel, similar approaches in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven meningioma grade I, II and III * Progression is defined as growing meningiomas on 2 different Magnetic Resonance Imaging (MRI) 3 to 6 months apart * Patients must have failed surgery, and not amenable to a new curative intended surgery * Patients must have failed radiotherapy and/or radiosurgery * Patients who have given their written consent * No contra indication to Alpelisib and Trametinib * No receiving other investigational agents * Written informed consent * Adequate bone marrow function * Adequate liver function as shown by * Adequate renal function Exclusion Criteria: * Contra indication to Alpelisib and Trametinib * Women of child-bearing age who are using no effective means of contraception * Pregnant or breast-feeding women * Patients receiving other investigational agents * Known intolerance or hypersensitivity to Alpelisib and Trametinib * Uncontrolled diabetes mellitus * Patients who have any severe and uncontrolled medical condition * Patients receiving chronic treatment with immunosuppressives * Patients with a known history of HIV seropositivity * Patients who have a history of another primary malignancy less than or equal to 3 years, with * the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
Where this trial is running
Marseille
- Assistance Publique Hôpitaux de Marseille — Marseille, France (RECRUITING)
Study contacts
- Study coordinator: Thomas GRAILLON, PH
- Email: thomas.graillon@ap-hm.fr
- Phone: 491385545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Meningioma