Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas
Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a secondary
role. Unlike other sites, many of these tumors are not amenable to complete resection either
because of anatomical location, and sometimes they only can be biopsied. A substantial number
of children will have recurrences following resection or will experience progression
following incomplete tumor removal or biopsy.
Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins
are known to increase the sensitivity of gliomas to anti-tumor agents. Their association
could be administered for long periods, in the hope of much reduced risk of toxicities.
This is a national, multicentric, interventional, open-label, non-comparative, and
non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in
combination with fixed-dose of Celebrex.
This project involves 10 SFCE health centers accustomed to phase I / II studies(Société
Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French
Society for the Fight against Cancer and Leukemia in Children and Adolescents).
Phase:
Phase 1
Details
Lead Sponsor:
Centre Oscar Lambret
Collaborators:
Anticancer Fund, Belgium Reliable Cancer Therapies