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Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: rosiglitazone maleate (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Electron Kebebew, MD, Principal Investigator, Affiliation: University of California, San Francisco

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.

Clinical Details

Official title: A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer

Study design: Primary Purpose: Treatment

Primary outcome: Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Secondary outcome: Side effects of drug at 2 months

Detailed description: OBJECTIVES: Primary

- Determine complete response in patients with locoregionally extensive or metastatic

differentiated thyroid cancer treated with rosiglitazone. Secondary

- Compare the long-term response of patients treated with this drug with historical

controls.

- Determine the toxicity profile of this drug in these patients.

- Determine the presence/persistence of tumor in patients treated with this drug.

- Determine the quality of life of patients treated with this drug.

- Determine overall survival of patients treated with this drug.

OUTLINE: This is a pilot study. Patients receive oral rosiglitazone once daily on weeks 1-8. Patients also receive oral liothyronine sodium twice daily on weeks 1-6 in preparation for radioactive iodine scan. Treatment continues in the absence of disease progression or unacceptable toxicity. At week 8, all patients undergo whole body radioactive iodine scan followed by a treatment dose of radioiodine to assess radioiodine uptake by tumor. Quality of life is assessed at baseline and at the end of study treatment. Patients are followed at 2 weeks, 1, 4, and 10 months, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2004
Last updated: January 3, 2014

Page last updated: August 20, 2015

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