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Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer
Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.
The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Shiga
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Otsu, Shiga, Japan, 520-2192
- Department of Medical Oncology, Shiga University of Medical Science Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Advanced NSCLC that cannot undergo curative surgery.
- Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
- Histologically diagnosed NSCLC.
- Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
- ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
- Life expectancy > 3 months.
- Age between 20 to 79
- Male or Female.
- In patients or out patients.
- Able and willing to give valid written informed consent.
Exclusion Criteria:
- Other malignancy requiring treatment
- radiation, immunotherapy, hyperthermia, or surgery.
- Active and uncontrolled infectious disease
- Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
- Autoimmune disease.
- HIV-Ab or antigen positive
- Prior anti-cancer therapy within 4 weeks
- Laboratory values as follows: 2000<mm3 < WBC < 15000/mm3, Platelet count < 50000/mm3, Asparate transaminase > 5 X cutoff value, Alanine transaminase > 5 X cutoff value, Total bilirubin > 3 X cutoff value, and Serum creatinine > 3X cutoff value.
- Patients knows HLA-A type.
- Breastfeeding and Pregnancy (woman of child bearing potential)
- Refusal of pregnancy conception.
- Treated with S-488401, S-488402, or S-488403.
- Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
- Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: S-488410
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In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each).
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
Tijdsspanne: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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CTL response between HLA-A24:02 and non-HLA-A24:02
Tijdsspanne: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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PFS and ORR between HLA-A24:02 and non-HLA-A24:02
Tijdsspanne: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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PFS and OS between CTL response positive and negative
Tijdsspanne: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence
Tijdsspanne: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Identification of biomarkers for efficacy and safety that are mentioned above
Tijdsspanne: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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. doi: 10.1111/j.1349-7006.2007.00603.x.
- 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. doi: 10.1158/0008-5472.CAN-07-3243.
- 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.
- 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.
- 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. doi: 10.1158/0008-5472.CAN-06-2137.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- S488410LP
- UMIN000007873 (Register-ID: UMIN: University Hospital Medical Information Network)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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