Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase I Window, Dose Escalating and Safety Trial of Metformin in Combination With Induction Chemotherapy in Relapsed Refractory Acute Lymphoblastic Leukemia: Metformin With Induction Chemotherapy of Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD)
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.
This will be a phase I protocol of Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and metformin conducted in the Sunshine Project sites for children with recurrent ALL. All sites will be eligible to open this study, provided they agree to adhere to all study procedures and make a good faith effort to obtain all pharmacodynamic and pharmacokinetic evaluations requested. ;
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