Clinical trialNCT01528046CompletedPhase 1Interventional

Metformin in Children With Relapsed or Refractory Solid Tumors

SponsorH. Lee Moffitt Cancer Center and Research InstituteEnrollment26Primary Brain TumorsSolid Tumors

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Damon Reed, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator
clinicaltrials.gov ↗
Jonathan Gill, M.D.
The Children's Hospital at Montefiore, Pediatric Cancer Foundation, Sunshine Project
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Connecticut Children'S Medical Center
Hartford, Connecticut, United States
Nemours/alfred I. Dupont Hospital for Children, Delaware
Wilmington, Delaware, United States
University of Florida
Gainesville, Florida, United States
Nemours Children'S Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Johns Hopkins All Children'S Hospital
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
the Children'S Hospital at Montefiore
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States
Primary Children'S Medical Center/utah
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Irinotecan →Metformin →Temozolomide →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Sept 2012
Primary completion: 26 Sept 2019
Completion: 3 Feb 2020
Last update posted: 13 Jan 2023
Registered enrollment: 26
Registry id: NCT01528046

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.