drugset / Trial / NCT01324180

Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL)

NCT01324180

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2011-07-18
Primary completion
2016-11-16
Completion
2017-07-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule Oral
Background Cytarabine Small molecule 30 mg Intrathecal
Background Cytarabine Small molecule 50 mg Intrathecal
Background Cytarabine Small molecule 70 mg Intrathecal
Background Dexamethasone Small molecule 10 mg/m2 Oral
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Methotrexate Small molecule Intrathecal
Background Pegaspargase Protein / enzyme biologic 2500 unknown Intramuscular
Background Vincristine Small molecule 1.5 mg/m2 Intravenous