Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
A Phase I Study to Evaluate the Safety and Efficacy of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
調査の概要
詳細な説明
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.
For each indication (cancer of the lung or liver) 10 patients are anticipated to be recruited, making a total of 20 subjects. All subjects will receive treatment as this is a single-arm study.
研究の種類
入学 (実際)
段階
- フェーズ 1
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:
- subjects had voluntarily given written informed consent
- subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit
- subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC
- subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC
- subjects' ECOG performance status ≤ 2
- subjects with life expectancy ≥ 3 months
Exclusion Criteria:
- subjects with medical history of gout
- subjects who had participated other clinical trials within 4 weeks before the screening visit
- subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit
- subjects with clinically significant diseases other than cancer
- subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit
- female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception
- subjects with history of alcohol, drug or other substance abuse
- subjects with disease of bacteremia
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：Late stage lung cancer and liver cancer
Immune Killer Cells (IKC)
|
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 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety]
時間枠：5 months
|
Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment
|
5 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response Evaluation Criteria in Solid Tumors (RECIST)
時間枠：4 months
|
Record net changes of tumor sizes
|
4 months
|
|
Quality of Life (QOL)
時間枠：5 months
|
The assessment will be performed using The World Heath Organization Quality of Life Questionnaire (WHOQOL) This questionnaire produces a quality of life profile. It is possible to derive four domain scores. The four domain scores denote an individual's perception of quality of life in each particular domain (1. Physical health 2. Psychological 3. Social relationships 4. Environmental) Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score (min: 0 max: 100) Domain scores are then calculated (divide domain score by 4) to produce a final QOL Score (i.e. higher scores denote higher quality of life min: 0 max:100). |
5 months
|
協力者と研究者
捜査官
- 主任研究者：Kuo-Ching Yang, MD, PhD、Shin Kong Wu Ho-Su Memorial Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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。