Intratumoral Cisplatin for Resectable NSCLC
A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer
PRIMARY OBJECTIVE:
To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol
DESIGN: 3+3 dose escalation.
調査の概要
詳細な説明
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the United States. Even for early stage disease, the rate of recurrence following surgical resection is as high as 50%. Although neoadjuvant therapy, administered before surgery, for early stage lung cancer is associated with a survival benefit, it is rarely used due to the systemic toxicity of intravenous (IV) cytotoxic chemotherapy. IV immunotherapies are also being evaluated in combination with systemic therapies in the neoadjuvant setting. However, only a minority of patients respond to immunotherapy. One of the most common reasons for failure of immunotherapy is lack of presentation of tumor antigens to the immune system, a problem that may be potentially addressed with cytotoxic agents.
Over the last several years, case series have demonstrated the feasibility and safety of delivering cisplatin directly into lung tumors. Given the current knowledge of safety and tolerability of intratumoral cisplatin, coupled with the potential to achieve immune priming that may help address systemic micrometastases, the investigators postulate that intratumoral cisplatin will be well-tolerated, and potentially effective, neoadjuvant therapy for patients with early stage, resectable, non-small cell lung cancer.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Ardren Sara
- 電話番号:8026563795
- メール:sara.ardren@uvmhealth.org
研究場所
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Vermont
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Burlington、Vermont、アメリカ、05405
- 募集
- University of Vermont
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コンタクト:
- Sara Ardren
- 電話番号:802-656-3795
- メール:sara.ardren@uvmhealth.org
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コンタクト:
- C. Matthew Kinsey
- 電話番号:8026563525
- メール:Matt.Kinsey@uvmhealth.org
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-
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
Inclusion Criteria:
- Age ≥18 years.
- Eastern Cooperative Oncology Group performance status 0 or 1
Patients must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/microliter
- Platelets ≥100,000/microliter
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- Aspartate aminotransferase /Alanine aminotransferase ≤3 × institutional upper limit of normal
- Creatinine ≤ institutional ULN
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Have known or suspected clinical stage I-IIb NSCLC after computed tomography (CT) and/or positron emission tomography at time of enrollment
- Presence of a target lesion with a minimum volume of 1.0 cm3, (approximately1.2 cm in diameter) and ≤ 5.0 cm in diameter
- Agreement from a cardiothoracic surgeon, following review of past medical history, medications, pulmonary function testing, and CT scan that patient is likely to be a surgical candidate and that, after considering known possible adverse events, delivery of intratumoral cisplatin is unlikely to adversely affect surgical feasibility
- Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (per the determination of a trained, attending, cytopathologist). No research procedures will be performed if ROSE is non-diagnostic
- A CT scan of the chest (with or without contrast) within 1 month of the screening visit
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Use of an investigational agent within 30 days of the screening visit
- IV chemotherapy within the 30 days of the screening visit
- Pregnancy/lactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by University of Vermont Medical Center Policy
- History of prior radiation to the study lesion
- History of allergic reaction to cisplatin or its derivatives
- Patients with uncontrolled intercurrent illness
- Physician determination that patient would not be appropriate for study
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
- 割り当て:なし
- 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:Intratumoral Cisplatin Arm
Single arm approach.
There is no comparator or placebo group.
Cisplatin will be administered directly into a non-small cell lung cancer, following imaging verification and pathologic diagnosis, during a single bronchoscopic procedure.
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Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
他の名前:
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Rate of dose limiting toxicity
時間枠:Within 2 weeks of delivery
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Adverse events as defined using the Common Terminology Criteria for Adverse Events
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Within 2 weeks of delivery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Major pathologic response
時間枠:Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery
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Evaluation of the tissue response to the drug
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Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery
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Blood biomarker panel
時間枠:Assessed from blood drawn on day of bronchoscopy and day of surgical resection
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Includes serum cytokine analysis, mass cytometry for inflammatory cells, and complete blood count
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Assessed from blood drawn on day of bronchoscopy and day of surgical resection
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Tissue biomarker panel
時間枠:Assessed from tissue obtained on day of bronchoscopy and day of surgical resection
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Includes evaluation of cellular constituents and sequencing of cells present in tissue
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Assessed from tissue obtained on day of bronchoscopy and day of surgical resection
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協力者と研究者
スポンサー
捜査官
- 主任研究者:C. Matthew Kinsey, MD, MPH、University of Vermont
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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。
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