Clinical trial · Interventional
Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
NCT00525135CI-TRIAL-00016762terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left university and study was halted prematurely. No data was analyzed.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valproic Acid | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- 1
- description
- 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.
- interventionNames
- Drug: Valproic Acid
- type
- OTHER
- label
- 2
- description
- 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.
- interventionNames
- Drug: Valproic Acid
Primary outcomes (2)
- measure
- Decrease in Thyroglobulin Level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.