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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
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 CenterSan Francisco, California  94115