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Trial record 70 of 2037 for:    cancer vaccine

Safety Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01069640
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Yataro Daigo, Shiga University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2010
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.
Biological: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides
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 Name: URLC10

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.
Biological: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides
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 Name: URLC10

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.
Biological: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides
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 Name: URLC10




Primary Outcome Measures :
  1. Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy. [ Time Frame: 2 months ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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*0201 or HLA-A*0206
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069640


Locations
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Japan
Shiga University of Medical Science Hospital
Otsu, Shiga, Japan, 520-2192
Sponsors and Collaborators
Shiga University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
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Principal Investigator: Yataro Daigo, MD, PhD Department of Medical Oncology, Shiga University of Medical Science
Publications:

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Responsible Party: Yataro Daigo, Professor, Director of Cancer Center, Shiga University
ClinicalTrials.gov Identifier: NCT01069640    
Other Study ID Numbers: SUMS-21-73
UMIN000003190 ( Other Identifier: UMIN )
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Yataro Daigo, Shiga University:
URLC10
lung cancer
vaccine
HLA-A*0201
HLA-A*0206
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms