- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01069640
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive Advanced Non-small Cell Lung Cancer
March 15, 2019 updated by: Yataro Daigo, Shiga University
Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*02 (URLC10) in Patients With Non-small Cell Lung Cancer Refractory to Standard Therapy
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*0201 or HLA-A*0206 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators previously identified three novel HLA-A*0201 or HLA-A*0206-restricted epitope peptides, which were derived from a cancer-testis antigen, URLC10, as targets for cancer vaccination against lung cancer.
In this phase I trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HHLA-A*0201 or HLA-A*0206-positive advanced non-small cell lung cancer patients who failed to standard therapy.
Study Type
Interventional
Enrollment (Anticipated)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shiga
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Otsu, Shiga, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
- ECOG performance status 0-2
- Age between 20 to 85
- Clinical efficacy can be evaluated by some methods
- No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks
- Life expectancy > 3 months
- 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
- HLA-A*0201 or HLA-A*0206
- Able and willing to give valid written informed consent
Exclusion Criteria:
- Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
- Myocardial infarction within six months before entry
- Breastfeeding and Pregnancy (woman of child bearing potential)
- Active and uncontrolled infectious disease
- Concurrent treatment with steroids or immunosuppressing agent
- Other malignancy requiring treatment
- Non-cured traumatic wound
- Decision of unsuitableness by principal investigator or physician-in-charge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: URLC10-1mg
Patients will be vaccinated once a week for four weeks of a treatment cycle.
On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
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Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle.
Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Other Names:
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Experimental: URLC10-2mg
Patients will be vaccinated once a week for four weeks of a treatment cycle.
On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
|
Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle.
Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Other Names:
|
Experimental: URLC10-3mg
Patients will be vaccinated once a week for four weeks of a treatment cycle.
On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
|
Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle.
Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.
Time Frame: 2 months
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2 months
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Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.
Time Frame: 2 months
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2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.
Time Frame: 2 months (every time point(s) at which each course is completed)
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2 months (every time point(s) at which each course is completed)
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Immunological responses: Peptides specific CTL, Antigen cascade, Regulatory T cells, Cancer antigens and HLA levels.
Time Frame: 2 months (every time point(s) at which each course is completed)
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2 months (every time point(s) at which each course is completed)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
February 16, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimate)
February 17, 2010
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 15, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUMS-21-73
- UMIN000003190 (Other Identifier: UMIN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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