A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Decrease in thyroglobulin level and tumor size
Outcome Time Frame:
16 months
Safety Issue:
No
Principal Investigator
Electron Kebebew, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Institutional Review Board
Study ID:
Valproic Acid
NCT ID:
NCT00525135
Start Date:
August 2007
Completion Date:
March 2009
Related Keywords:
- Head and Neck Cancer
- Thyroid Neoplasms
- Head and Neck Neoplasms
Name | Location |
|---|---|
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
