Spots Global Cancer Trial Database for Metformin in Children With Relapsed or Refractory Solid Tumors
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Trial Identification
Brief Title: Metformin in Children With Relapsed or Refractory Solid Tumors
Official Title: A Phase I Trial of Dose Escalation of Metformin in Combination With Vincristine, Irinotecan, and Temozolomide in Children With Relapsed or Refractory Solid Tumors
Study ID: NCT01528046
Study Description
Brief 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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint Petersburg, Florida, United States
Tampa General Hospital, Tampa, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, 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, 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
Contact Details
Name: Jonathan Gill, M.D.
Affiliation: The Children's Hospital at Montefiore, Pediatric Cancer Foundation, Sunshine Project
Role: STUDY_CHAIR
Name: Damon Reed, M.D.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
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