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

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

July 18, 2011

Primary Completion Date

November 16, 2016

Study Completion Date

July 27, 2017

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Metformin

Will be dosed orally BID as per dose level of subject as defined in dose escalation schema. Both liquid and tablet forms are allowed and can be chosen based on convenience. Metformin will be continued throughout the cycle until Day 28 or until the patient is removed from study (e.g. to pursue new lines of therapy such as transplant), whichever occurs sooner.

DRUG

Vincristine

1.5 mg/m\^2/dose IV push (maximum single dose 2 mg) on days 2, 9, 16 and 23

DRUG

Dexamethasone

"* 10 mg/m\^2/day divided BID~* Take dexamethasone by mouth days 2-15"

DRUG

PEG-asparaginase

"* 2500 IU's/m\^2/day~* Intramuscular injection (IM) or intravenous infusion per institutional standard on days 3, 9, 16 and 23~* If the patient develops an allergic reaction to PEG while being treated on this protocol, eliminate all future doses of PEG and substitute Erwinia if not intolerant of Erwinia and has no history of pancreatitis.~* Patients will receive Erwinase® 25,000 IU/m\^2 x 6 doses intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase on the original protocol."

DRUG

Doxorubicin

60 mg/m\^2/day IV over 15 minutes on day 2

DRUG

Intrathecal chemotherapy

"IT cytarabine given intrathecally to all patients on day 1 of each cycle. Dose defined by age. May be given with staging lumbar puncture before enrollment, but must be within 72 hours of starting therapy. If not done at study entry or before, may be done on Day 2 prior to doxorubicin administration.~* 30 mg for patients age 1-1.99~* 50 mg for patients age 2-2.99~* 70 mg for patients greater than 3 years of age IT methotrexate given Intrathecally to all patients who are CNS negative at study entry on day 16 at the dose defined by age."

Trial Locations (5)

10467

Montefiore Medical Center, The Children's Hospital at Montefiore, The Bronx

32806

Arnold Palmer Hospital for Children, Orlando

33136

Holtz Children's Hospital University of Miami Miller School of Medicine, Miami

33701

All Children's Hospital, St. Petersburg

43205

Nationwide Children's Hospital, Columbus

All Listed Sponsors
collaborator

Pediatric Cancer Foundation

OTHER

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT01324180 - Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL) | Biotech Hunter | Biotech Hunter