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

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Valproic Acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00525135

Valproic Acid

Details and patient eligibility

About

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.

Full description

PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

1

Other group

Description:

If a patient exhibits increased radioiodine uptake on the Thyrogen scan post valproic acid therapy, patients will then prepare for ablative treatment and will remain on valproic acid for a total of 16 weeks, until receiving RAI ablation.

Treatment:

Drug: Valproic Acid

2

Other group

Description:

If no increased uptake is seen, patients will continue on valproic acid for 6 additional weeks at an increased dosage, totaling an overall treatment time of 16 weeks as well.

Treatment:

Drug: Valproic Acid