Phase 2 Thyroid Cancer Trial, Completed

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed (either at first diagnosis or at relapse) with one of these cancers: rhabdomyosarcoma (a muscle tissue cancer), Wilms tumor (a kidney cancer), hepatocellular carcinoma (a liver cancer), or papillary thyroid carcinoma (a type of thyroid cancer)
• People whose cancer has come back or has stopped responding to treatment
• People who have at least one measurable tumour visible on an MRI or CT scan, where the tumour is at least 10mm in size (certain findings such as fluid collections, bone marrow involvement, or results only seen on nuclear medicine scans do not count as measurable disease for this trial)
• People with hepatocellular carcinoma whose cancer has come back or stopped responding to standard chemotherapy
• People with papillary thyroid carcinoma whose cancer has stopped responding to radioactive iodine treatment
• People whose cancer has no known curative treatment or treatment proven to extend life with an acceptable quality of life
• People with brain metastases only if those metastases were treated with surgery or radiation and have been stable with no new growth for at least 3 months
• People with rhabdomyosarcoma or Wilms tumor who are at least 24 months old and no older than 30 years old at the time of enrolment
• People with hepatocellular carcinoma who are at least 24 months old and under 18 years old at the time of enrolment
• People with papillary thyroid carcinoma who are at least 24 months old and no older than 21 years old at the time of enrolment
• People with a performance status score of at least 50% on standard health and function scales (meaning they are able to carry out some daily activities, including those who use a wheelchair due to paralysis)
• People with adequate blood cell counts: a neutrophil count of at least 1,000/µL, platelets of at least 75,000/µL without recent transfusions, and haemoglobin of at least 8.0 g/dL
• People with adequate kidney function based on age- and gender-appropriate creatinine levels or kidney filtration rate (confirm specific values with trial site)
• People with adequate liver function, including normal or near-normal bilirubin, liver enzyme (ALT), and blood clotting test results
• People with normal lipase and amylase levels (enzymes related to pancreas function)
• People with no breathing difficulty at rest, no inability to exercise due to breathing problems, and oxygen levels above 94% if tested
• People whose blood pressure is within the normal range for their age, height, and gender, and who are not taking medication for high blood pressure
• People who agree to use effective contraception from the time of signing the consent form until at least 30 days after the last dose of the study drug
• Girls who have started their periods must have a negative pregnancy test before joining

Who may not be able to join:

• People who are pregnant or breastfeeding
• People with symptoms of liver failure such as confusion related to liver disease (hepatic encephalopathy) or fluid build-up in the abdomen (ascites)
• People with an infection that is not under control
• People with a known tendency to bleed abnormally (bleeding diathesis)
• People with a condition called Gilbert syndrome (a liver condition affecting bilirubin processing)
• People who, in the investigator's opinion, may not be able to follow the safety monitoring requirements of the study
• People who have previously been treated with sorafenib (the drug being studied in this trial)
• People currently receiving any other chemotherapy, radiation therapy, immune-modifying treatments, or other experimental treatments
• People who have not fully recovered from the side effects of previous chemotherapy, immunotherapy, or radiation treatment
• People with solid tumours who received chemotherapy that suppresses bone marrow within the past 3 weeks (or 6 weeks if the prior treatment was a specific type called a nitrosourea)
• People who received a growth factor medication within the past 7 days (or 14 days for a long-acting version called pegfilgrastim)
• People who received a biological therapy within the past 7 days — or longer if that therapy is known to cause side effects beyond 7 days
• People who received a monoclonal antibody treatment and fewer than three half-lives of that drug have passed since the last dose (confirm timing with trial site)
• People who have not waited long enough after radiation therapy — wait times vary depending on the type and area treated (ranging from 2 weeks to 6 months depending on the situation)
• People who have had a stem cell transplant within the past 2 months, or who show signs of active graft-versus-host disease
• People with papillary thyroid carcinoma who received radioactive iodine treatment within the past 3 weeks
• People currently taking corticosteroid medications whose dose has not been stable or decreasing for at least 7 days before enrolment
• People currently taking another experimental drug as part of another study
• People currently taking anti-cancer medications other than the study drug
• People taking medications to prevent organ rejection or graft-versus-host disease after a transplant (such as cyclosporine or tacrolimus)
• People taking certain anti-seizure medications (phenytoin, carbamazepine, or phenobarbital), the antibiotic rifampin, grapefruit juice, or the herbal supplement St. John's Wort
• People on therapeutic anticoagulation (blood-thinning treatment at full treatment doses) — low-dose preventive anticoagulation for medical devices may be allowed if blood clotting results meet the required levels (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.