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)
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
MTD determined by Dose Limiting Toxicity (DLT), any time during the first course of therapy. Dose Limiting Toxicities: Any Grade 3 or 4 non-hematological toxicity by Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 felt to be probably or definitely related to the study agent, persistent marrow aplasia at day 44, lactic acidosis for grade 3 or 4, grade 3 and 4 hypoglycemia.
John M. Goldberg, M.D.
Holtz Children's Hospital University of Miami Miller School of Medicine
United States: Food and Drug Administration
|Nemours Children's Clinic||Jacksonville, Florida 32207|
|All Children's Hospital||St. Petersburg, Florida 33701|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|M.D. Anderson of Orlando||Orlando, Florida 32806|
|Holtz Children's Hospital University of Miami Miller School of Medicine||Miami, Florida 33136|
|Montefiore Medical Center, The Children's Hospital at Montefiore||Bronx, New York 10467|