Metformin in Children With Relapsed or Refractory Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 25
Summary
- Conditions
- Primary Brain Tumors
- Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 18 years
- Gender
- Both males and females
Description
Metformin is an oral anti-diabetes medication that activates AMP-activated protein kinase (AMPK). Recent data from in vitro and in vivo experiments, as well as epidemiologic retrospective analyses, suggest that metformin has anti-cancer activity. Vincristine, irinotecan, and temozolomide (VIT) is a ...
Metformin is an oral anti-diabetes medication that activates AMP-activated protein kinase (AMPK). Recent data from in vitro and in vivo experiments, as well as epidemiologic retrospective analyses, suggest that metformin has anti-cancer activity. Vincristine, irinotecan, and temozolomide (VIT) is a combination of chemotherapeutic agents that have different mechanisms of action as well as disparate side effect profiles. Two recent phase 1 trials have demonstrated that this regimen is safe and well-tolerated in children with relapsed and refractory solid tumors.
Tracking Information
- NCT #
- NCT01528046
- Collaborators
- Pediatric Cancer Foundation
- Investigators
- Study Chair: Jonathan Gill, M.D. The Children's Hospital at Montefiore, Pediatric Cancer Foundation, Sunshine Project Principal Investigator: Damon Reed, M.D. H. Lee Moffitt Cancer Center and Research Institute
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