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CompletedNCT01069653Updated Mar 19, 2019

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

A Phase 1 interventional study of HLA-A*2402-restricted CDCA1 and KIF20A peptides in Small Cell Lung Cancer, sponsored by Shiga University. Completed at 1 site in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-03-19.

Sponsored by Shiga University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
20 Years to 85 Years
Sex
All
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Study summary

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 restricted epitope peptides CDCA1 and KIF20A emulsified with Montanide ISA 51 for advanced small cell lung cancers.

Read the detailed description

The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from two cancer-testis antigens, CDCA1 and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these two 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.

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Conditions studied

  • Small Cell Lung Cancer

Keywords

  • CDCA1
  • KIF20A
  • lung cancer
  • vaccine
  • HLA-A*2402
03

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 9 is below the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Shiga University is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. SCLC 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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    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 CDCA1 peptide (1mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

    Biological: HLA-A*2402-restricted CDCA1 and KIF20A peptides

  • Experimental
    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 CDCA1 peptide (2mg) and KIF20A peptide(2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

    Biological: HLA-A*2402-restricted CDCA1 and KIF20A peptides

  • Experimental
    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 CDCA1 peptide (3mg) and KIF20A peptide(3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

    Biological: HLA-A*2402-restricted CDCA1 and KIF20A peptides

Interventions

  • BiologicalHLA-A*2402-restricted 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.

    Also known as: CDCA1 and KIF20A

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What researchers measure

Primary outcomes

  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 outcomes

  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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Study locations

1 site
  • Shiga University of Medical Science Hospital
    Ōtsu, Shiga 520-2192, Japan
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References and documents

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. PubMed 19459850 ↗
  • 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. PubMed 18770861 ↗
  • 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. PubMed 18452554 ↗
  • 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. PubMed 18297458 ↗
  • 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. PubMed 18089789 ↗
  • 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. PubMed 17784873 ↗
  • 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. PubMed 17079454 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of Mar 2019 and a completion of Mar 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2010
First posted
Feb 17, 2010
Start
Feb 2010
Primary completionActual
Mar 2019
CompletionActual
Mar 2019
Last update
Mar 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01069653
Lead sponsor
Shiga University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
Responsible party
Yataro Daigo (Professor, Director of Cancer Center, Shiga University) — Principal investigator
First posted
Feb 17, 2010
Start date
Feb 2010
Primary completion
Mar 2019
Completion
Mar 2019
Last update
Mar 19, 2019

Study contacts

Yataro Daigo, MD, PhD
principal investigator · Department of Medical Oncology, Shiga University of Medical Science

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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