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A Phase I Trial of Dose Escalation of Metformin in Combination with Vincristine, Irinotecan, and Temozolomide in Children with Relapsed or Refractory Solid Tumors
H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting for participants. 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.
Primary Objectives: 1.To determine the maximum tolerated dose (MTD) of metformin when given in conjunction with VIT in children with refractory and relapsed solid tumors. 2.To describe the pharmacokinetics of metformin in children with relapsed malignancies receiving VIT combination chemotherapy. Secondary Objectives: 1.To evaluate the antitumor activity of the addition of metformin to VIT. 2.To define the pharmacodynamics of metformin. 3.To determine tissue and tumor metformin concentrations in patients undergoing resection.