RAD001 for Patients With Radioiodine Refractory Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title: A Phase II Trial Using RAD001 for Patients With Radioiodine Refractory Thyroid Cancer

Status Completed

Clinical Trial Summary

Since thyroid cancer becomes refractory to radioactive iodine, treatment options are very limited. Tyrosine kinase inhibitors such as sorafenib have recently shown promise. This trial seeks to expand treatment options for this disease with a new, oral drug called RAD001. It is an inhibitor of the mTOR pathway and has shown activity in neuroendocrine cancers of the gastrointestinal tract and has been approved for the treatment of metastatic renal cell cancer.

Clinical Trial Description

• RAD001 will be taken once a day in the morning starting on Day 1 and continue until the participant is no longer participating in the study treatment.

• A history and physical exam will be performed the first day of the study and then once a month. Blood tests including coagulation studies, and thyroid studies will be performed monthly. A urine sample will need to be provided on the first day of treatment and then every 2 months. Imaging consisting of a CT or MRI of the neck, chest and abdomen will be done every 8 weeks after starting RAD001.

• Participants will remain on this research study for up to 24 months. However, if the participants doctor feels that they are benefiting from the study drug and they do not have severe side effects, they may be given the option to continue taking RAD001. ;

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

• NCT number: NCT00936858
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: July 2009
• Completion date: February 27, 2020