Metformin in Children With Relapsed or Refractory Solid Tumors

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the tolerability and safety of escalating doses of metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with recurrent and refractory solid tumors.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01528046
Study type	Interventional
Source	H. Lee Moffitt Cancer Center and Research Institute
Contact
Status	Completed
Phase	Phase 1
Start date	September 24, 2012
Completion date	February 3, 2020

View Details

See also
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