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

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Valproic Acid

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