NCT01528046

Metformin in Children With Relapsed or Refractory Solid Tumors

A Phase I Trial of Dose Escalation of Metformin in Combination With Vincristine, Irinotecan, and Temozolomide in Children With Relapsed or Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumors
• Primary Brain Tumors

Interventions

Type	Name	Description
DRUG	Vincristine	Vincristine (VCR) = 1.5 mg/m\^2/day (maximum dose 2 mg), days 1 and 8, administered as intravenous (IV) bolus over 1-5 minutes
DRUG	Irinotecan	Irinotecan (IRN) = 50 mg/m\^2/day, days 1-5, IV over 60 minutes
DRUG	Temozolomide	Temozolomide (TEM) = 50 mg/m\^2/day by mouth (PO) Days 1-5
DRUG	Metformin	Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.

Timeline

• Start date: 2012-09-24
• Primary completion: 2019-09-26
• Completion: 2020-02-03
• First posted: 2012-02-07
• Last updated: 2023-01-13

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study