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

NCT ID: NCT00525135

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-03-31

Brief 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.

Detailed 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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: OTHER

Valproic Acid

Intervention Type: DRUG

OUTLINE: This is a pilot study.

Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.

Quality of life is assessed at the end of every week through a study diary.

Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.

2

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.

Group Type: OTHER

Valproic Acid

Intervention Type: DRUG

OUTLINE: This is a pilot study.

Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.

Quality of life is assessed at the end of every week through a study diary.

Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.

Interventions

Valproic Acid

OUTLINE: This is a pilot study.

Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.

Quality of life is assessed at the end of every week through a study diary.

Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Electron Kebebew, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

Valproic Acid

Identifier Type: -

Identifier Source: org_study_id