Metformin in Children With Relapsed or Refractory Solid Tumors

Phase 1 Completed 26 enrolled H. Lee Moffitt Cancer Center and Research Institute Pediatric Cancer Foundation · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2012-09-24
Primary completion: 2019-09-26
Completion: 2020-02-03

Publications

Metts JL, Trucco M, Weiser DA, Thompson P, Sandler E, Smith T, Crimella J, Sansil S, Thapa R, Fridley BL, Llosa N, Badgett T, Gorlick R, Reed D, Gill J. A phase I trial of metformin in combination with vincristine, irinotecan, and temozolomide in children with relapsed or refractory solid and central nervous system tumors: A report from the national pediatric cancer foundation. Cancer Med. 2023 Feb;12(4):4270-4281. doi: 10.1002/cam4.5297. Epub 2022 Sep 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	666 mg/m2	Oral
Subject	Metformin	Small molecule	999 mg/m2	Oral
Subject	Metformin	Small molecule	1333 mg/m2	Oral
Subject	Metformin	Small molecule	1666 mg/m2	Oral
Subject	Metformin	Small molecule	2000 mg/m2	Oral
Background	Irinotecan	Small molecule	50 mg/m2	Intravenous
Background	Temozolomide	Small molecule	50 mg/m2	Oral
Background	Vincristine	Small molecule	1.5 mg/m2	Intravenous

Metformin in Children With Relapsed or Refractory Solid Tumors

Summary

Timeline

Publications

Drugs

Indications