Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
San Francisco、California、アメリカ、94115
- UCSF Helen Diller Family Comprehensive Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
|---|
|
Radioiodine uptake and thyroglobulin level at 6 months and 1 year
|
二次結果の測定
結果測定 |
|---|
|
Side effects of drug at 2 months
|
協力者と研究者
捜査官
- 主任研究者：Electron Kebebew, MD、University of California, San Francisco
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CDR0000398114
- UCSF-03201
- UCSF-H28355-22994-01
- GSK-UCSF-H28355-22994-01
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。