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

Head and Neck Cancer Clinical Trial

Official title:

A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00525135
• Other study ID #: Valproic Acid
• Status: Terminated
• Phase: Phase 2
• First received: August 28, 2007
• Last updated: January 21, 2015
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: January 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Thyroid Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Thyroglobulin Level	Number of participants with decreased thyroglobulin level after study treatment	Baseline, 16 weeks	No
Primary	Decrease in Tumor Size	Number of participants with decreased tumor size after study treatment	Baseline, 16 weeks	No
Secondary	Increased Radioactive Iodine Uptake	Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy	Baseline, 10 weeks	No
Secondary	Side Effects of Drugs Affecting Quality of Life	Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment	17 weeks	Yes
Secondary	Survival		up to 10 years post-study treatment	No