Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer

Completed · Phase 2

Conditions studied: Childhood Hepatocellular Carcinoma, Papillary Thyroid Cancer, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Rhabdomyosarcoma, Recurrent Thyroid Cancer, Recurrent Wilms Tumor and Other Childhood Kidney Tumors

In brief

This phase II trial studies how well sorafenib tosylate works in treating younger patients with relapsed or refractory rhabdomyosarcoma, Wilms tumor, liver cancer, or thyroid cancer. Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01502410

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2012-01-01

Expected to finish

2014-06-01

Last updated by the study team

2018-06-26

Who can join

Age: 2 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse:
• Rhabdomyosarcoma (RMS)
• Wilms tumor
• Hepatocellular carcinoma (HCC)
• Papillary thyroid carcinoma (PTC)
• Patients must have relapsed or refractory disease (RMS, Wilms tumor, HCC, PTC)
• Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
• The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium, or positron emission tomography [PET] scans)
• Elevated tumor markers in plasma or cerebrospinal fluid(CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the requirements noted above
• Patients with HCC must be relapsed or refractory to conventional chemotherapy
• Patients with PTC must be refractory to radioactive iodine (RAI)
• 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
• Patients with known metastasis to the brain will be excluded from trial participation unless treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months
• Rhabdomyosarcoma and Wilms strata: patients must be ≥ 24 months and ≤ 30 years of age at study enrollment
• Hepatocellular carcinoma (HCC): patients must be ≥ 24 months and < 18 years of age at study enrollment
• Papillary thyroid carcinoma (PTC): patients must be ≥ 24 months and ≤ 21 years of age at study enrollment
• Patients must have a Lansky or Karnofsky performance status score of ≥ 50%, corresponding to ECOG categories 0, 1, or 2
• Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
• Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• Nemours Children's Clinic - Jacksonville — Jacksonville, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Saint Joseph Children's Hospital of Tampa — Tampa, Florida, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Saint Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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