NCT00525135

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

February 3, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

August 28, 2007

Results QC Date

January 21, 2015

Last Update Submit

January 21, 2015

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • Decrease in Thyroglobulin Level

    Number of participants with decreased thyroglobulin level after study treatment

    Baseline, 16 weeks

  • Decrease in Tumor Size

    Number of participants with decreased tumor size after study treatment

    Baseline, 16 weeks

Secondary Outcomes (3)

  • Increased Radioactive Iodine Uptake

    Baseline, 10 weeks

  • Side Effects of Drugs Affecting Quality of Life

    17 weeks

  • Survival

    up to 10 years post-study treatment

Study Arms (2)

1

OTHER

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

2

OTHER

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

Interventions

Valproic AcidDRUG

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.

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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Results Point of Contact

Title
UCSF PRS Administrator
Organization
University of California San Francisco
Elaine.Cooperstein@ucsf.edu
415-502-3212

Study Officials

  • Electron Kebebew, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2007

First Posted

September 5, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 3, 2015

Results First Posted

February 3, 2015

Record last verified: 2015-01

Locations

US(1)