Solid Tumor Treatment with Axitinib – Phase I

Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children with Recurrent or Refractory Solid Tumors

Protocol Description

The goal of this multicenter trial by the Children’s Oncology Group is to determine acceptable dosage limits for axitinib in pediatric patients with recurrent or refractory solid tumors. Additional goals will be to measure assessment of a tumor’s response to the drug. Vascular endothelial growth factor (VEGF) is a growth signal that is needed for development of blood vessels in tumor cells. Axitinib is a VEGF receptor tyrosine kinase inhibitor that has been previously tested against cancer cells in laboratory settings and in adults. Blocking VEGF decreases the formation of tumor blood vessels and in other studies VEGF blockade has led to decrease in tumor size.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders ages 1 to 17, who have been diagnosed as having recurrent or refractory solid tumors, and certain renal cell carcinomas.
Males and Females: Ages 1 to 17 years


Patients enrolled in the study will take axitinib orally twice a day for 28-day cycles. Participants may continue to receive treatment for up to 24 cycles, barring serious side effects or worsening of their tumors.
Visits: Weekly during the first 28 days of therapy, clinic visits once per month with weekly blood work for subsequent cycles
Duration: Up to 2 years, depending on outcomes

Status: Enrollment is limited. Please call to check status.

Source(s) of Support

Children’s Oncology Group (ADVL1315)
National Cancer Institute, Cancer Therapy Evaluation Program
Pfizer, Inc.

Primary Investigator

Andrew J. Bukowinski, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN