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

Phase 2TerminatedNCT00525135

University of California, San Francisco5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Valproic AcidDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Decrease in Thyroglobulin Level

Number of participants with decreased thyroglobulin level after study treatment

Time frame: Baseline, 16 weeks

Decrease in Tumor Size

Number of participants with decreased tumor size after study treatment

Time frame: Baseline, 16 weeks

Secondary Outcomes

Increased Radioactive Iodine Uptake

Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy

Time frame: Baseline, 10 weeks

Side Effects of Drugs Affecting Quality of Life

Number of participants experiencing \> Grade 1 adverse events (including fatigue) attributable to study treatment

Time frame: 17 weeks

Survival

Time frame: up to 10 years post-study treatment

Data from ClinicalTrials.gov

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