A Phase II Study of Sorafenib in Children and Young Adults with Relapsed/Refractory Rhabdomyosarcoma, Wilms Tumor, Hepatocellular Carcinoma, or Papillary Thyroid Cancer

Protocol
12-139
Full Title
A Phase II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (IND# 69896) in Children and Young Adults with Relapsed/Refractory Rhabdomyosarcoma, Wilms Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma (COG-ADVL1121)
Purpose

Sorafenib is an anticancer drug approved for the treatment of adult liver and kidney cancers. In this Children’s Oncology Group study, researchers are assessing the safety and effectiveness of sorafenib in children and young adults with rhabdomyosarcoma, Wilms tumor, hepatocellular carcinoma, and papillary thyroid cancer that has returned or continues to grow despite standard therapy.

Sorafenib works by stopping a signal made by cancer cells that they need to multiply and grow, and through inhibiting blood supply to cancer cells. It is a capsule that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have rhabdomyosarcoma, Wilms tumor, hepatocellular carcinoma, or papillary thyroid cancer that has returned or continues to grow despite standard therapy.
  • Patients with rhabdomyosarcoma or Wilms tumor must be at least age 2 and no older than 30. Those with hepatocellular carcinoma must be at least 2 and under age 18. Patients with papillary thyroid cancer must be at least 2 and no older than 21.
  • Patients must have recovered from the serious side effects of prior therapies prior to entering the study.

For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.

Disease(s)
Hepatobiliary: Liver Cancer
Kidney Cancer
Sarcomas: Rhabdomyosarcoma
Thyroid Cancer
Locations