Thyroid Neoplasm Clinical Trial
Official title:
A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Origin
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.
Background:
Patients who have advanced differentiated thyroid cancers (Stage IV) have a five-year
survival of only 25%. Clinically this results in more aggressive growth, metastasis,
decreased or loss of iodine uptake in the tumor, and tumors that may be refractory to
conventional treatment: surgical resection, radioactive iodine treatment and thyroid hormone
for Thyroid Stimulating Hormone (TSH) suppression.
In thyroid cancer, valproic acid, at clinically achievable concentrations, has an
antiproliferative and differentiating effect.
We hypothesize that valproic acid may inhibit proliferation and induce differentiation in
thyroid cancer cells so that 131-I may detect residual disease and be more effective for
radioiodine ablation of thyroid cancer cells of follicular cell origin.
Objectives:
The primary goal of this study is to determine if valproic acid will have an antineoplastic
and differentiation effect in patients with advanced and or metastatic thyroid cancer of
follicular cell origin.
Eligibility:
Unresectable advanced and/or poorly differentiated thyroid cancers of follicular cell origin
(excluding anaplastic and medullary thyroid cancer) that have no uptake (less than 1%) on
radioiodine scan or are unresponsive to radioiodine therapy.
Elevated serum thyroglobulin (Tg) level (greater than 100ng/ml on thyroid hormone; greater
than 10ng/ml off thyroid hormone).
Design:
This will be an open label phase II study to assess the efficacy of valproic acid therapy as
an antiproliferative and differentiation agent in patients with incurable differentiated
thyroid cancer (unresponsive and/or radioiodine negative and unresectable).
Oral valproic acid will be administered to reach a therapeutic serum level (50 to 100
microgram/ml).
The number of patients to be enrolled is 25 with an interim analysis of response once 13
patients are evaluable for response. It is anticipated that five patients may be enrolled per
year.
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