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Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Valproic Acid
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Decrease in Thyroglobulin Level
Number of participants with decreased thyroglobulin level after study treatment
Decrease in Tumor Size
Number of participants with decreased tumor size after study treatment

Secondary Outcome Measures

Increased Radioactive Iodine Uptake
Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy
Side Effects of Drugs Affecting Quality of Life
Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment
Survival

Full Information

First Posted
August 28, 2007
Last Updated
January 21, 2015
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00525135
Brief Title
Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
PI left university and study was halted prematurely. No data was analyzed.
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm 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.
Arm Title
2
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Valproic Acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in Thyroglobulin Level
Description
Number of participants with decreased thyroglobulin level after study treatment
Time Frame
Baseline, 16 weeks
Title
Decrease in Tumor Size
Description
Number of participants with decreased tumor size after study treatment
Time Frame
Baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Increased Radioactive Iodine Uptake
Description
Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy
Time Frame
Baseline, 10 weeks
Title
Side Effects of Drugs Affecting Quality of Life
Description
Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment
Time Frame
17 weeks
Title
Survival
Time Frame
up to 10 years post-study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electron Kebebew, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer

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