IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients. (IDOvaccine)
IDO Peptid Vaccination in Combination With Immune Stimulating Agent Aldara and the Adjuvant Montanide, for Treatment of Patients With Locally Advanced or Metastatic Non Small-cell Lung Cancer. A First-in-man Phase I Trial.
Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the adjuvant Montanide, for treatment of patients with locally advanced or metastatic non small-cell lung cancer. A first-in-man phase I trial.
Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as a possible anticancer target.
調査の概要
詳細な説明
Background: Non small-cell lung cancer (NSCLC) is a common disease with a poor prognosis when locally advanced or metastasized, despite advances in surgery, chemo- and radiation therapy.
In this trial the investigators assess a new immunotherapeutic strategy targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as a possible anticancer target.
IDO has recently been recognized as an important factor in immune regulation and development of immune tolerance in the microenvironment of cancer cells. Cells that represent IDO at their surface are known to inhibit the immune system. IDO expression is seen both in cancer cells and antigen presenting cells. The vaccination against IDO expressing cells is therefore two-sided. The vaccination therapy is thought to block the development of immune tolerance induced by IDO expressing cells. At the same time the investigators aim to stimulate the production of IDO specific T-cells, hence facilitating the elimination of IDO positive tumour cells. The primary end points are safety and toxicity evaluation. Secondary end points are immunological and clinical response.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Copenhagen
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Herlev、Copenhagen、デンマーク、2730
- Center for Cancer ImmuneTherapy
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Herlev, Copenhagen
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Copenhagen、Herlev, Copenhagen、デンマーク、2730
- Center for Cancer Immune Therapy, Dept. og Haematology/Oncology
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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:
1. Histological or cytological verified non small cell lung cancer 2. Metastatic or locally advanced incurable stage III-IV NSCLC 3. Patients need to be off chemotherapy treatment 4. Evaluable disease according to RECIST V. 1,1 criteria 5. Patients must be HLA-A2 positive 6. Patients > 18 years old 7. Performance status 0-1 8. Life expectancy of > 3 months 9. Acceptable bone marrow function, defined as
a. White blood cell count > 2,5 * 109 /l b. Neutrophil count> 1,5 * 109 /l c. Platelet count > 75 * 109/l 10. Creatinin measured < 2,5 * upper limit value 11. Acceptable liver function, defined as
- ASAT < 100 U/L
Bilirubin < 30 U/L 12. Women with child-bearing potential must have controlled s-hcg before inclusion 13. Patients must provide written informed concent before inclusion 13. Termination of chemotherapy treatment > 28 days before inclusion
14. Termination of radiotherapy treatment > 28 days before inclusion
15. Inclusion at least > 4 weeks after complicated gastric surgery
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Exclusion Criteria:
- Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion
- Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression
- Patients with active gastric ulcer disease; patients taking antacid treatment can be included.
- Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease
- Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)
- Severe allergic reaction or previous anaphylactic shock
- Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)
- Pregnant or lactating women
- Psychiatric disease, which can influence compliance
- Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape.
- Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)
- Treatment with other experimental therapy
- Treatment with other anti-cancer therapy, except from treatment of osteoporosis
No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion.
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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 |
|---|---|
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実験的：Indeolamine 2,3 deoxygenase
To inhibit immune suppression and tolerance, by blocking the IDO enzyme with vaccination against IDO.
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Vaccination every second week
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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 |
|---|---|---|
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evidence of toxicity
時間枠：12 months
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CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity
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12 months
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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 |
|---|---|---|
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evaluation of immunological and clinical responses
時間枠：18 months
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immunological assays will be used to identify immunological responses.
CT scans will be used for evaluation of clinical responses.
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18 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Trine Zeeberg Iversen, MD、Center for Cancer Immune Therapy
出版物と役立つリンク
一般刊行物
- Iversen TZ, Engell-Noerregaard L, Ellebaek E, Andersen R, Larsen SK, Bjoern J, Zeyher C, Gouttefangeas C, Thomsen BM, Holm B, Thor Straten P, Mellemgaard A, Andersen MH, Svane IM. Long-lasting disease stabilization in the absence of toxicity in metastatic lung cancer patients vaccinated with an epitope derived from indoleamine 2,3 dioxygenase. Clin Cancer Res. 2014 Jan 1;20(1):221-32. doi: 10.1158/1078-0432.CCR-13-1560. Epub 2013 Nov 11.
- Andersen MH. The specific targeting of immune regulation: T-cell responses against Indoleamine 2,3-dioxygenase. Cancer Immunol Immunother. 2012 Aug;61(8):1289-97. doi: 10.1007/s00262-012-1234-4. Epub 2012 Mar 3.
研究記録日
主要日程の研究
研究開始
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 (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
- LU 1006 - IDO
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。
NSCLCの臨床試験
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Centre Oscar LambretUniversity Hospital, Lille終了しました
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Xiaorong Dongわからない
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Fondazione Policlinico Universitario Agostino Gemelli...完了
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Spanish Lung Cancer Group完了
IDO peptide vaccinationの臨床試験
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Herlev Hospital完了
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University of California, DavisNational Cancer Institute (NCI); IO Biotech募集ステージ 0a 膀胱がん AJCC v8 | ステージ 0is 膀胱がん AJCC v8 | ステージ I 膀胱がん AJCC v8 | 高リスクの非筋肉浸潤性膀胱尿路上皮がんアメリカ
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Hospital Universitari Vall d'Hebron Research Institute募集
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Edward KimBristol-Myers Squibb; National Cancer Institute (NCI)終了しました切除不能な肝細胞がん | ステージ III 肝細胞がん AJCC v8 | ステージ IIIA 肝細胞がん AJCC v8 | ステージ IV 肝細胞がん AJCC v8 | ステージ IVA 肝細胞がん AJCC v8 | ステージ IVB 肝細胞がん AJCC v8 | ステージ IIIB 肝細胞がん AJCC v8 | 転移性肝細胞がんアメリカ
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Thomas Jefferson UniversityBristol-Myers Squibb積極的、募集していない
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Northwestern UniversityNational Cancer Institute (NCI)積極的、募集していない