Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Non-small Cell Lung Cancer

This study is currently recruiting participants.
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:
NCT01069575
First received: February 16, 2010
Last updated: September 16, 2013
Last verified: September 2013

February 16, 2010
September 16, 2013
February 2010
October 2015   (final data collection date for primary outcome measure)
  • 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 ]
Evaluation of safety (NCI CTCAE version3) and tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) as well as adverse effects of vaccination therapy, and determination of the recommended dose for next phase trial. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01069575 on ClinicalTrials.gov Archive Site
  • Immunological responses including 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 ]
  • 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 ]
Not Provided
Not Provided
 
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Non-small Cell Lung Cancer
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

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.

The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, 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 HLA-A*2402-positive advanced non-small cell lung cancer patients who failed to standard therapy.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A 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, CDCA1, and KIF20A
  • Experimental: URLC10-CDCA1-KIF20A 1mg
    Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted URLC10 peptide (1mg), CDCA1 peptide (1mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
    Intervention: Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides
  • Experimental: URLC10-CDCA1-KIF20A 2mg
    Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted URLC10 peptide (2mg), CDCA1 peptide (2mg) and KIF20A peptide(2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
    Intervention: Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides
  • Experimental: URLC10-CDCA1-KIF20A 3mg
    Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted URLC10 peptide (3mg), CDCA1 peptide (3mg) and KIF20A peptide(3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
    Intervention: Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact: Yataro Daigo, MD, PhD 81-77-548-2111 ydaigo@belle.shiga-med.ac.jp
Japan
 
NCT01069575
SUMS-21-72, UMIN000003189
Yes
Yataro Daigo, Shiga University
Shiga University
Human Genome Center, Institute of Medical Science, University of Tokyo
Principal Investigator: Yataro Daigo, MD, PhD Department of Medical Oncology, Shiga University of Medical Science
Shiga University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP