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

NCT01069640 | Completed Phase 1 DMC

• 2 other identifiers: SUMS-21-73UMIN000003190
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

URLC10; lung cancer; vaccine; HLA-A*0201; HLA-A*0206

Outcome Measures

Primary Outcomes (2)

• Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.

  2 months

• Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.

  2 months

Secondary Outcomes (2)

• Immunological responses: Peptides specific CTL, Antigen cascade, Regulatory T cells, Cancer antigens and HLA levels.

  2 months (every time point(s) at which each course is completed)

• Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.

  2 months (every time point(s) at which each course is completed)

Study Arms (3)

URLC10-1mg

EXPERIMENTAL

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

URLC10-2mg

EXPERIMENTAL

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

URLC10-3mg

EXPERIMENTAL

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

Interventions

HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides BIOLOGICAL

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: URLC10

URLC10-1mg; URLC10-2mg; URLC10-3mg

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiga University: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

Related Publications (7)

• 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.

  PMID: 19459850 BACKGROUND

• 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.

  PMID: 18770861 BACKGROUND

• 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.

  PMID: 18452554 BACKGROUND

• 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.

  PMID: 18297458 BACKGROUND

• 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.

  PMID: 18089789 BACKGROUND

• 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.

  PMID: 17784873 BACKGROUND

• 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.

  PMID: 17079454 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

HLA-A*02:01 antigen; LY6K protein, human

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yataro Daigo, MD, PhD

  Department of Medical Oncology, Shiga University of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Cancer Center

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

JP (1)