RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
2013年2月20日 更新者：Jochen Lorch, MD、Dana-Farber Cancer Institute
A Phase I Trial Using RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
RAD001 is approved by the U.S Food and Drug Administration (FDA) to treat advanced kidney cancer.
This drug has also been used in other research studies to evaluate its effectiveness in other cancers.
Information from these research studies suggests that RAD001 may help to decrease the growth and development of tumor cells by reducing the blood supply that tumors need to grow.
In this research study, we are trying to determine the safety of RAD001 when given to people with locally advanced head and neck cancer in combination with cisplatin and radiation.
We are also looking for the highest dose of RAD001 that can be given to people safely.
調査の概要
詳細な説明
- Most patients receiving treatment for head and neck cancer will develop difficulty swallowing food and drinking liquids during the course of therapy. For this reason, it will be recommended that a PEG (percutaneous endoscopic gastrostomy) tube be placed in the participants stomach prior to undergoing the study regimen. This is to help maintain weight and nutritional health.
- Since we are looking for highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates will receive the same dose of RAD001 or cisplatin.
- The study regimen will last for seven weeks. During each week of study participation the following will occur: Radiation will be administered each weekday (5 days per week). Cisplatin will be given intravenously at the start of each week. RAD001 will be given to the participant to take at home. Participants will take the study drug once a day in the morning starting on day 1.
- A history and physical exam will be performed weekly while participant's are receiving radiation treatment. Blood tests for routine laboratory testing will be performed weekly.
- Each month for the first two months after participants finish radiation therapy and stop taking RAD001 and cisplatin, they will have a physical ezam, a neurologic exam, and blood tests. X-rays, a CT, MRI and/or PET scans will also be performed a the two month visit. After the first two months, follow-up will continue every 1-2 months for the first year. Additionally, every 6 months for the first two years, follow-up visits will include an assessment of speech and swallowing functions along with X-rays, CT, MRI and/or PET scans.
研究の種類
介入
入学 (実際)
3
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02115
- Dana-Farber Cancer Institute
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients with stage III/IV, locally advanced, biopsy proven squamous cell cancer of the head and neck who are planned to undergo chemoradiation as their primary treatment with curative intent. Patients with oropharynx, hypopharynx, larynx primaries, nasopharynx as well as those with documented SCC of the cervical lymph nodes, with unknown primaries, are eligible.
- Patients must have at least evaluable disease and one measurable site of disease according to RECIST criteria is desirable.
- 18 years of age or older
- Minimum of two weeks since any major surgery
- WHO performance status of 2 or less
- Adequate bone marrow, liver, and renal function as outlined in the protocol
Exclusion Criteria:
- Presence of distant metastatic disease
- Prior chemotherapy
- Prior radiation to the head and neck or adjacent anatomical site
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- Other malignancies within the past 3 years except for adequately treated carcinoma of the thyroid, cervix or basal or squamous cell carcinomas of the skin
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Uncontrolled diabetes mellitus
- A known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
- Women who are pregnant or breastfeeding, or women/men able to conceive and unwilling to practice an effective method of birth control
- Patients who have received prior treatment with an mTOR inhibitor
- Patients with a known hypersensitivity to RAD001 or other rapamycins or to its excipients
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Rad001 with cisplatin
|
Administered daily 5 days per week
他の名前：
Taken orally once a day
Administered intravenously once a week
|
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 |
時間枠 |
|---|---|
|
To evaluate the maximum tolerated dose (MTD) and safety of the RAD001 in combination with weekly cisplatin and radiation in patients with locally advanced HNSCC.
時間枠：2 years
|
2 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Obtain preliminary results on efficacy of the RAD001, cisplatin and radiation therapy combination in patients with locally advanced HNSCC.
時間枠：3 years
|
3 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jochen Lorch, MD、Dana-Farber Cancer Institute
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年2月1日
一次修了 (実際)
2012年2月1日
試験登録日
最初に提出
2010年1月26日
QC基準を満たした最初の提出物
2010年1月26日
最初の投稿 (見積もり)
2010年1月28日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年2月22日
QC基準を満たした最後の更新が送信されました
2013年2月20日
最終確認日
2013年2月1日
詳しくは
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。