A Phase 2 interventional study of Valproic Acid in Head and Neck Cancer, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-03.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
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.
802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's enrollment of 5 is below the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS
PATIENT CHARACTERISTICS
-18 years or older
Entry lab results:
EXCLUSION CRITERIA:
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.
Drug: 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.
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.
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
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
| Milestone | Study Intervention |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
Number of participants with decreased thyroglobulin level after study treatment
| participants | Study Intervention |
|---|---|
| Decrease in Thyroglobulin Level | 0 |
Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy
| participants | Study Intervention |
|---|---|
| Increased Radioactive Iodine Uptake | 3 |
Number of participants experiencing \> Grade 1 adverse events (including fatigue) attributable to study treatment
| participants | Study Intervention |
|---|---|
| Side Effects of Drugs Affecting Quality of Life | 0 |
Number of participants with decreased tumor size after study treatment
| participants | Study Intervention |
|---|---|
| Decrease in Tumor Size | 0 |
No measurements were reported for this outcome.
Collected over 17 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Intervention | — | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Study Intervention |
|---|---|
| Mean | NA ± NA |
| Sex: Female, Male(Participants) | Study Intervention |
|---|---|
| Female | NA |
| Male | NA |
| Region of Enrollment(participants) | Study Intervention |
|---|---|
| United States | 5 |
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco