A Phase I Study of Pazopanib as a Single Agent for Children With Refractory Solid Tumors

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01130623
First received: May 25, 2010
Last updated: December 30, 2011
Last verified: November 2011
  Purpose

Background:

- Pazopanib, a drug that inhibits the growth of new blood vessels in tumors, was recently approved by the Food and Drug Administration to treat advanced kidney cancer in adults. Pazopanib has been used in only a small number of adults, and more research is needed on whether it is safe and effective to use in children. Researchers are interested in determining safe and effective treatment doses of pazopanib in children, and in other studies will examine which form of pazopanib treatment (tablet or liquid) is most effective and well tolerated.

Objectives:

  • To determine a safe and effective dose of pazopanib to treat solid tumors in children.
  • To study the effects of pazopanib on blood cells, blood flow, and human development.

Eligibility:

- Children, adolescents, and young adults between 1 and 21 years of age who have been diagnosed with solid tumors that have not responded to treatment.

Design:

  • Eligible participants will be screened with a physical examination, blood and tumor samples, and imaging studies.
  • Participants will receive pazopanib tablets for 28-day cycles of treatment. Pazopanib should be taken on an empty stomach, at least 1hour before or 2 hours after a meal. Participants may receive pazopanib for up to 24 cycles unless the tumor does not respond or participants develop serious side effects.
  • Blood samples will be taken on days 1, 15, 22, and 27 of the first cycle of pazopanib, with additional samples taken every 8 weeks during subsequent cycles.
  • An optional part of the study will collect additional blood samples at regular intervals for 24 hours after the first dose of pazopanib and at regular intervals after another dose during the second or third week of the first treatment cycle.

Condition Intervention Phase
Sarcoma
Neuroblastoma
Wilms Tumor
Osteosarcoma
Brain Tumor
Drug: Pazopanib (GW786034)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Pazopanib as a Single Agent for Children With Relapsed or Refractory Solid Tumors, Including CNS Tumors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To estimate MTD and Phase II dose of oral pazopanib.
  • To define the toxicities of oral pazopanib tablet or suspension.
  • To characterize PKs.

Secondary Outcome Measures:
  • To define antitumor and biologic activity and explore changes in tumor vascular permeability. To assess VEGF haplotype/phenotype relationships and explore concentration-effect with biomarkers and clinical outcomes.

Enrollment: 0
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pazopanib (GW786034)
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Eligibility:
  • Part 1 (Phase I Dose Escalation) and 2a (Suspension Formulation Component):

    --Patients greater than 12 months and less than or equal to 21 years of age with measureable or evaluable relapsed or refractory solid tumors including CNS tumors with histologic verification except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevation of tumor markers.

  • Part 2b (Expanded Imaging Cohort):

    --Patients greater than 2 years and less than or equal to 25 years of age with histologically verified relapsed or refractory soft tissue sarcoma, desmoplastic small round cell tumor or extraosseus Ewing sarcoma with measurable disease (greater than or equal to 2 cm) in the head, neck, extremity or fixed within the thorax, abdomen or pelvis.

  • Performance score: Karnofsky greater than or equal to 50% for patients 16 years of age; Lansky greater than or equal to 50 for patients less than or equal to 16 years of age.
  • Must have fully recovered from acute toxic effects from all prior therapy which have been completed within the specified prior time frame. Have adequate organ function as determined by laboratory evaluation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130623

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Responsible Party: CTEP/National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT01130623     History of Changes
Other Study ID Numbers: 100120, 10-C-0120
Study First Received: May 25, 2010
Last Updated: December 30, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Wilms Tumor
VEGF Inhibitor
Maximum Tolerated Dose
Dose Escalation
Pharmacokinetics
Antitumor Activity
Pediatric Cancer
Solid Tumor
Sarcoma
Neuroblastoma
Osteosarcoma
Brain Tumor

Additional relevant MeSH terms:
Wilms Tumor
Brain Neoplasms
Neoplasms
Neuroblastoma
Osteosarcoma
Sarcoma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Genetic Diseases, Inborn
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Bone Tissue
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplastic Syndromes, Hereditary
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Urogenital Neoplasms
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014