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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Shiga University
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Yataro Daigo, Shiga University
ClinicalTrials.gov Identifier:
NCT01069640
First received: February 16, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shiga University:

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

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: February 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069640

Contacts
Contact: Yataro Daigo, MD, PhD 81-77-548-2111 ydaigo@belle.shiga-med.ac.jp

Locations
Japan
Shiga University of Medical Science Hospital Recruiting
Otsu, Shiga, Japan, 520-2192
Contact: Yataro Daigo, MD, PhD    81-77-548-2111    ydaigo@belle.shiga-med.ac.jp   
Sponsors and Collaborators
Shiga University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Principal Investigator: Yataro Daigo, MD, PhD Department of Medical Oncology, Shiga University of Medical Science
  More Information

Publications:

Responsible Party: Yataro Daigo, Professor, Director of Cancer Center, Shiga University
ClinicalTrials.gov Identifier: NCT01069640     History of Changes
Other Study ID Numbers: SUMS-21-73, UMIN000003190
Study First Received: February 16, 2010
Last Updated: September 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Shiga University:
URLC10
lung cancer
vaccine
HLA-A*0201
HLA-A*0206

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014