MedTrace Logo

Metformin in Children With Relapsed or Refractory Solid Tumors

NCT01528046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-01-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the tolerability and safety of escalating doses of metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with recurrent and refractory solid tumors.

Conditions

Interventions

DRUG

Vincristine

Vincristine (VCR) = 1.5 mg/m\^2/day (maximum dose 2 mg), days 1 and 8, administered as intravenous (IV) bolus over 1-5 minutes

DRUG

Irinotecan

Irinotecan (IRN) = 50 mg/m\^2/day, days 1-5, IV over 60 minutes

DRUG

Temozolomide

Temozolomide (TEM) = 50 mg/m\^2/day by mouth (PO) Days 1-5

DRUG

Metformin

Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.

Sponsors & Collaborators

  • Pediatric Cancer Foundation

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jonathan Gill, M.D. · The Children's Hospital at Montefiore, Pediatric Cancer Foundation, Sunshine Project

  • Damon Reed, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-24
Primary Completion
2019-09-26
Completion
2020-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528046 on ClinicalTrials.gov