Non-Small Cell Lung Cancer Clinical Trial
Official title:
Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients With Non-small Cell Lung Cancer Refractory to Standard Therapy
Verified date | March 2019 |
Source | Shiga University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy 2. ECOG performance status 0-2 3. Age between 20 to 85 4. Clinical efficacy can be evaluated by some methods 5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks 6. Life expectancy > 3 months 7. Laboratory values as follows 1500/mm3 < WBC < 15000/mm3 Platelet count > 75000/mm3 Asparate transaminase < 3 X cutoff value Alanine transaminase < 3 X cutoff value Total bilirubin < 3 X cutoff value Serum creatinine < 2X cutoff value 8. HLA-A*2402 9. Able and willing to give valid written informed consent Exclusion Criteria: 1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. Myocardial infarction within six months before entry 3. Breastfeeding and Pregnancy (woman of child bearing potential) 4. Active and uncontrolled infectious disease 5. Concurrent treatment with steroids or immunosuppressing agent 6. Other malignancy requiring treatment 7. Non-cured traumatic wound 8. Decision of unsuitableness by principal investigator or physician-in-charge |
Country | Name | City | State |
---|---|---|---|
Japan | Shiga University of Medical Science Hospital | Otsu | Shiga |
Lead Sponsor | Collaborator |
---|---|
Shiga University | Human Genome Center, Institute of Medical Science, University of Tokyo |
Japan,
Daigo Y, Nakamura Y. From cancer genomics to thoracic oncology: discovery of new biomarkers and therapeutic targets for lung and esophageal carcinoma. Gen Thorac Cardiovasc Surg. 2008 Feb;56(2):43-53. doi: 10.1007/s11748-007-0211-x. Epub 2008 Feb 24. Review. — View Citation
Harao M, Hirata S, Irie A, Senju S, Nakatsura T, Komori H, Ikuta Y, Yokomine K, Imai K, Inoue M, Harada K, Mori T, Tsunoda T, Nakatsuru S, Daigo Y, Nomori H, Nakamura Y, Baba H, Nishimura Y. HLA-A2-restricted CTL epitopes of a novel lung cancer-associated cancer testis antigen, cell division cycle associated 1, can induce tumor-reactive CTL. Int J Cancer. 2008 Dec 1;123(11):2616-25. doi: 10.1002/ijc.23823. — View Citation
Hayama S, Daigo Y, Kato T, Ishikawa N, Yamabuki T, Miyamoto M, Ito T, Tsuchiya E, Kondo S, Nakamura Y. Activation of CDCA1-KNTC2, members of centromere protein complex, involved in pulmonary carcinogenesis. Cancer Res. 2006 Nov 1;66(21):10339-48. — View Citation
Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. — View Citation
Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14. — View Citation
Mizukami Y, Kono K, Daigo Y, Takano A, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Detection of novel cancer-testis antigen-specific T-cell responses in TIL, regional lymph nodes, and PBL in patients with esophageal squamous cell carcinoma. Cancer Sci. 2008 Jul;99(7):1448-54. doi: 10.1111/j.1349-7006.2008.00844.x. Epub 2008 Apr 30. — View Citation
Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy. | 2 months | ||
Primary | Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial. | 2 months | ||
Secondary | Immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels | 2 months (every time point(s) at which each course is completed) | ||
Secondary | Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival. | 2 months (every time point(s) at which each course is completed) |
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