Clinical trialNCT01324180CompletedPhase 1Interventional

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

SponsorH. Lee Moffitt Cancer Center and Research InstituteEnrollment14Acute Lymphoblastic Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Damon Reed, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator
clinicaltrials.gov ↗
Julio M. Barredo, M.D.
Holtz Children's Hospital University of Miami Miller School of Medicine
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Holtz Children'S Hospital University of Miami Miller School of Medicine
Miami, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
All Children'S Hospital
St. Petersburg, Florida, United States
Montefiore Medical Center, the Children'S Hospital at Montefiore
The Bronx, New York, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Dexamethasone →Doxorubicin →Intrathecal chemotherapyMetformin →Pegaspargase →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 18 Jul 2011
Primary completion: 16 Nov 2016
Completion: 27 Jul 2017
Last update posted: 7 Aug 2017
Registered enrollment: 14
Registry id: NCT01324180

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.