NCT00098852

Brief Summary

RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2009

Enrollment Period

5.7 years

First QC Date

December 8, 2004

Last Update Submit

January 3, 2014

Conditions

Head and Neck Cancer

Keywords

recurrent thyroid cancerstage II follicular thyroid cancerstage IV follicular thyroid cancerstage II papillary thyroid cancerstage IV papillary thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Secondary Outcomes (1)

  • Side effects of drug at 2 months

Interventions

rosiglitazone maleateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of differentiated thyroid cancer * Locoregionally extensive and/or metastatic disease * Inoperable disease * Failed prior conventional therapy that included total/near-total thyroidectomy AND radioactive iodine I 131 ablation therapy * Elevated thyroglobulin (Tg) levels (\> 3 ng/mL on thyroid hormone OR \> 10 ng/mL off thyroid hormone) * Tg-antibody positive patients are eligible despite the Tg level * Radioactive iodine (RAI) scan showing no or therapeutically insignificant (\< 1%) RAI uptake after thyroid hormone withdrawal * Scan performed within the past 18 months PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ 10 g/dL * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 50,000/mm\^3 Hepatic * ALT ≤ 2 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No New York Heart Association class III or IV cardiac disease Other * Not pregnant * No nursing within the past 3 months * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to thiazolidinediones * No other malignancy except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 3 months since prior chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent levothyroxine Radiotherapy * See Disease Characteristics * No prior cumulative dose of radioiodine ≥ 800 mCi * Prior adjuvant or therapeutic external beam radiotherapy allowed Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Kebebew E, Reiff E, Greenspan FS, et al.: Rosiglitazone treatment induces radioiodine uptake in some patients with radioiodine-negative thyroglobulin-positive differentiated thyroid cancer. [Abstract] The Endocrine Society's 87th Annual Meeting, 4-7 June 2005, San Diego, CA. A-P3-573, 2005. Also available online. Last accessed February 21, 2006.

    RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsThyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, Papillary

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinoma, Papillary

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Electron Kebebew, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2004

First Posted

December 9, 2004

Study Start

October 1, 2004

Primary Completion

June 1, 2010

Last Updated

January 6, 2014

Record last verified: 2009-01

Locations

US(1)