H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,
but will not be recruiting locally.
The purpose of the trial is to study the clinical and biological effects of metformin in
combination with standard systemic chemotherapy in a disease (relapsed ALL) that has a dismal
outcome, as well as to do a dose escalation study to find the Maximum Tolerated Dose (MTD) of
metformin in conjunction with ALL therapy. There have also been analysis of patients enrolled
on trials who were diabetics on metformin and their outcome was better than patients on the
same trial that were not on metformin as their antihyperglycemic.