ADVL1121, 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
Sorafenib will be given orally approximately every 12 hours daily continuously for 28-day cycles. Patients will be treated at 200 mg/m2/dose (maximum 400 mg/dose).
Tumor response will be evaluated and measured prior to every odd cycle. A cycle may be repeated every 28 days at the same dose if the patient has at least stable disease, continues to meet eligibility criteria, has not experienced a dose-limiting toxicity, and has not met one of the off protocol therapy or off study criteria. A cycle may be administered a maximum of 24 times.
≥ 24 months of age
≤ 30 years of age at study enrollment for Rhabdomysosarcoma and Wilms Tumor, < 18 years of age at study enrollment for Hepatocellular Carcinoma, and ≤ 21 years of age at study enrollment for Papillary Thyroid Carcinoma
Histologic verification of Rhabdomyosarcoma, Wilms Tumor, Hepatocellular Carcinoma, or Papillary Thyroid Carcinoma
Relapsed or refractory disease
Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
Lansky or Karnofsky Performance status of ≥ 50
Patient must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Adequate organ function