A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin
Completed · Phase 2
Conditions studied: Thyroid Neoplasm
In brief
Background: * Patients who have advanced thyroid cancer have a low long-term survival rate. These types of thyroid cancer do not respond well to conventional surgery or radiation, or to specific thyroid cancer treatments such as radioactive iodine treatment and thyroid hormone for thyroid stimulating hormone (TSH) suppression. * Valproic acid has long been approved as an anticonvulsant to treat seizures in patients with epilepsy. It has also been used to treat bipolar disorder. Recent studies have shown that valproic acid has promising effects in thyroid cancer treatment because it may help destroy cancer cells and help conventional treatments be more effective. However, valproic acid is not approved for thyroid cancer and is therefore an investigational drug. Objectives: * To determine whether valproic acid can inhibit tumor growth or induce tumor cell death. * To determine whether valproic acid can make tumor cells increase their uptake of radioiodine. Eligibility: \- Individuals at least 18 years of age who have advanced-stage thyroid cancer that is either unresponsive to conventional treatments or fails to absorb radioiodine. Design: * Eligible participants will continue on the standard thyroid hormone suppression therapy and begin receiving valproic acid for a total of 10 weeks. Participants will keep a study diary to record doses and side effects, and will have regular clinic visits to provide blood samples and receive additional valproic acid. * After 10 weeks, participants will have a Thyrogen scan to measure radioiodine uptake after valproic acid therapy. Tumor biopsies and blood samples will be taken at this time. * If there is increased radioiodine uptake on the scan, participants will have additional radioiodine therapy. * If there is no increased uptake on the scan, participants will continue on valproic acid for 7 more weeks. After 16 total weeks of treatment, additional blood samples and scans will be taken. Participants may continue to take valproic acid if the thyroid cancer appears to be responding to the treatment. * Follow-up visits will be scheduled at 3, 6, 9 (for patients continuing on valproic acid only), and 12 months.
Key facts
- Study ID
- NCT01182285
- Run by
- National Cancer Institute (NCI)
- People needed
- 13
- Starts
- 2010-09-24
- Expected to finish
- 2016-04-28
- Last updated by the study team
- 2018-05-16
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Allergy to valproic acid.
- Current coexisting malignancy other than basal cell carcinoma.
- Women of child-bearing potential who are pregnant or breastfeeding.
- Valproic acid is a known teratogen, causing primary neural tube defects, facial abnormalities, and skeletal malformation; therefore pregnant women will be excluded. Additionally, patients that become pregnant while on study protocol will be discontinued immediately.
- Active systemic infections, coagulation disorders or other major medical illnesses.
- Patients taking tolbutamide, warfarin, zidovudine, benzodiazepines, clonazepam, diazepam.
- Seizure disorder.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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