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Protocol No.PHO-GSK-FALLON-ADVL1322
StatusOPEN TO ACCRUAL
Principal InvestigatorFallon, Robert
ScopeNational
PhasePhase II
Age GroupChildren
TitleA Phase II Study of Pazopanib (GW786034, NSC# 737754 in Children, Adolescents and Young Adults with Refractory Solid Tumors
DescriptionThe purpose of this study is to find out what effects, good or bad, pazopanib (GW786034), National Service Center (NSC) # 737754, has on children, adolescents and young adults between 12 months and less than or equal to 18 years of age with relapsed or refractory rhabdomyosarcoma, non rhabdomyosarcomatous soft tissue sarcoma, Ewing sarcoma, relapsed or refractory osteosarcoma, neuroblastoma (measurable and/or evaluable), or hepatoblastoma. This is a two-stage open label phase II trial of pazopanib in children, adolescents and young adults with recurrent or refractory solid tumors. Eligible subjects will receive pazopanib daily as an oral tablet (450 mg/m^2/dose) or as a powder for suspension (225 mg/m^2/dose) in 28 day cycles. The maximum dose to be administered daily for tablets is 800 mg and for suspension 400 mg. Subjects will be closely monitored with clinical and laboratory observations for side effects. Response to treatment will be evaluated using appropriate imaging studies. In the absence of severe toxicity or progressive disease, subjects may continue receiving pazopanib.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Subjects must be at least 1 and less than or equal to 18 years of age at the time of study entry.
  • Subjects must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse
    • a) Rhabdomyosarcoma
    • b) Non-rhabdomyosarcomatous Soft Tissue Sarcoma (including desmoplastic small round cell tumor)
    • c) Ewing Sarcoma / Peripheral Primitive Neuroectodermal Tumor (PNET)
    • d) Osteosarcoma
    • e) Neuroblastoma (Measurable)
    • f) Neuroblastoma (Evaluable)
    • g) Hepatoblastoma.
For a full list of participation criteria, please visit ClinicalTrials.gov.
Applicable Disease SitesAny Site
Participating InstitutionsIndiana University (IU)
  • Riley Hospital for Children
Treatment TypeTreatment
ContactMelissa Lee, Phone: 317-944-4281
Pager: 312-1228
Email: mellee@iu.edu