Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00525135
Eligibility Criteria:
INCLUSION CRITERIA:
DISEASE CHARACTERISTICS
* Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive
* Cumulative dose of radioiodine \< 800 mCi
* No radioiodine uptake on whole body scan within 18 months of enrollment
* Inoperable extensive locoregional tumor mass and/or metastatic spread
* Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation
* Elevated thyroglobulin level (\>2ng/ml on thyroid hormone, \>10ng/ml off thyroid hormone)or Tg-antibody positive
PATIENT CHARACTERISTICS
-18 years or older
Entry lab results:
* Hemoglobin \> 8.0 gm/dl
* Absolute Neutrophil Count \> 750 cells/mm3
* Platelet count \> 75000/mm3
* BUN \< 1.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* Total protein \> 6.4
* Total bilirubin should be \< 1.5 times ULN.
* AST (SGOT), ALT (SGPT), ALKP and amylase \< 1.5 times ULN
* Amylase \< 1.5 times ULN
* Albumin \> 2.5
* Ammonia \< 1.5 times ULN
EXCLUSION CRITERIA:
* Not pregnant
* No nursing within the past 3 months
* No allergy to valproic acid
* No coexisting malignancy other than basal cell carcinoma
* No hepatic disease or significant dysfunction
* Karnofsky score \> 80
* No pancreatitis
* No kidney dysfunction
* Fertile patients must use effective contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00525135
Study Brief:
Protocol Section:
NCT00525135