Metformin in Children With Relapsed or Refractory Solid Tumors

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT01528046
Phase
PHASE1
Status
Completed

Conditions

  • Primary Brain Tumors
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Vincristine — DRUG
    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
  • Irinotecan — DRUG
    Irinotecan (IRN) = 50 mg/m\^2/day, days 1-5, IV over 60 minutes
  • Temozolomide — DRUG
    Temozolomide (TEM) = 50 mg/m\^2/day by mouth (PO) Days 1-5
  • Metformin — DRUG
    Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.

Study Details

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.

Key Dates

Start date
Sep 24, 2012
Status verified
Jan 2023
Primary completion
Sep 26, 2019
Completion
Feb 3, 2020

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin in Combination with VIT
    Participants will receive metformin in combination with vincristine, irinotecan and temozolomide (VIT).

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Average of 3 Months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06106-
Nemours/Alfred I. duPont Hospital for Children, DelawareWilmingtonDelaware19803-
University of FloridaGainesvilleFlorida32611-
Nemours Children's ClinicJacksonvilleFlorida32207-
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Tampa General HospitalTampaFlorida33606-
University of KentuckyLexingtonKentucky40536-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
The Children's Hospital at MontefioreThe BronxNew York10467-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Nationwide Children's HospitalColumbusOhio43205-
Primary Children's Medical Center/UtahSalt Lake CityUtah84113-

Find similar trials in Hartford, CT

By research site
Connecticut Children's Medical Center· Hartford, CTNemours/Alfred I. duPont Hospital for Children, Delaware· Wilmington, DEUniversity of Florida· Gainesville, FLNemours Children's Clinic· Jacksonville, FLUniversity of Miami Sylvester Comprehensive Cancer Center· Miami, FLJohns Hopkins All Children's Hospital· St. Petersburg, FL

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