Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer

Stopped early · Phase 2

Conditions studied: Head and Neck Cancer

In brief

RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.

Key facts

Study ID

NCT00525135

Run by

University of California, San Francisco

People needed

5

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2015-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Comprehensive Cancer Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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