Research

Tumor and Leukemia Treatment with Sorafenib - Phase I

Sorafenib in Treating Children with Refractory Solid Tumors or Refractory Leukemias

Protocol Description

The goal of this Children's Oncology Group Phase I study is to determine dosage parameters for sorafenib, a new experimental drug that may be effective against recurrent tumors or leukemias. Sorafenib blocks enzymes needed for cancer cell growth and blocks blood flow to the tumor. Sorafenib has been shown to be effective against cancer cells in adults with advanced kidney cancer and is also approved for use in adults with refractory solid tumors and refractory leukemias. Participants in this study will be the first children to be given sorafenib.

Eligibility Criteria

The group-wide study is currently accepting male and female patients 2 to 21 years of age who satisfy study criteria, and have been diagnosed with a recurrent or progressive tumor or leukemia that cannot be cured by any known standard treatment.
Boys: 2 to 21 years
Girls: 2 to 21 years

Requirements
Participants will receive sorafenib orally in tablet form for a length of one course, or 28 days. The course will be repeated up to 24 times as long as the participant is responding and not having harmful side effects. Throughout the length of the study, blood draws, physical exams and scans will be administered to monitor the child’s health and tumor status.
Visits: Number varies depending on participant’s response to chemotherapy.
Duration: Depending on outcomes, treatment may extend 2 years with patient’s health monitored after treatment ends.

Status: Open For Enrollment

Source of Support
Children's Oncology Group (Study ADVL0413)
National Cancer Institute

Additional Resources
Children’s Oncology Group CureSearch
Study Description at National Institutes of Health