Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
- Registration Number
- NCT00525135
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Valproic Acid 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. 2 Valproic Acid 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.
- Primary Outcome Measures
Name Time Method Decrease in Thyroglobulin Level Baseline, 16 weeks Number of participants with decreased thyroglobulin level after study treatment
Decrease in Tumor Size Baseline, 16 weeks Number of participants with decreased tumor size after study treatment
- Secondary Outcome Measures
Name Time Method Side Effects of Drugs Affecting Quality of Life 17 weeks Number of participants experiencing \> Grade 1 adverse events (including fatigue) attributable to study treatment
Survival up to 10 years post-study treatment Increased Radioactive Iodine Uptake Baseline, 10 weeks Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy
Trial Locations
- Locations (1)
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States