Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma

Part of paid clinical trials in Stanford, California.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00883688
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle").
  • Lapatinib — DRUG
    Pills of 700 mg/m\^2/dose given orally 2 times each day.

Study Details

The goal of this clinical research study is to learn if the combination of Avastin (bevacizumab) and Tykerb (lapatinib) can help to control ependymoma in pediatric patients. The safety of this drug combination will also be studied.

Key Dates

Start date
Jul 31, 2009
Status verified
Aug 2020
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

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

Arms

  • Experimental: Bevacizumab + Lapatinib
    Bevacizumab 10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle"). Lapatinib Pills of 700 mg/m\^2/dose given orally 2 times each day.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 4 weeks following treatment, repeat assessments up to one year. ]

Locations (6)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-
Children's Memorial HospitalChicagoIllinois60614-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PittsburghPittsburghPennsylvania15213-
St. Jude Children's Research HospitalMemphisTennessee38105-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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