Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: Valproic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Decrease in thyroglobulin level and tumor size [ Time Frame: 16 months ] [ Designated as safety issue: No ]
- Radioactive iodine uptake [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Side effects of drugs, quality of life and survival [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 5 |
| Study Start Date: | August 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
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
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. |
|
2
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Principal Investigator: | Electron Kebebew, MD | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00525135 History of Changes |
| Other Study ID Numbers: | Valproic Acid |
| Study First Received: | August 28, 2007 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Head and Neck Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Thyroid Diseases Valproic Acid Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013