Peptide Vaccine Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

Phase I Trial in Studying Peptide Vaccine Therapy Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874588
• Other study ID #: FVT-L0901
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2009
• Last updated: August 13, 2013
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2013
• Source: Fukushima Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Description:

URLC10 and CDCA1 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

Disease characteristics

1. Advanced or recurrent non small cell lung cancer

2. Second line or later therapeutic status

Patient characteristics

1. ECOG performance status 0-2

2. Life expectancy > 3 months

3. HLA-A*2402

4. Laboratory values as follows 1500/mm3<WBC<15000/mm3 Platelet count>75000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 99IU/L Alanine transaminase < 126IU/L Creatinine < 2.2mg/dl

5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)

2. Pregnancy (woman of child bearing potential)

3. Active and uncontrolled infectious disease

4. Adrenal cortical steroid hormone dependent status

5. Decision of unsuitableness by principal investigator

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Biological:
• HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2
Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 1.0mg and 3.0mg.

Locations

Country	Name	City	State
Japan	Fukushima Medical University	Fukushima

Sponsors (2)

Lead Sponsor	Collaborator
Fukushima Medical University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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. — View Citation

Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. — View Citation

Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment		3 months	Yes
Secondary	Peptides specific CTL responses in vitro		3 months	No
Secondary	Objective response rate as assessed using RECIST criteria		6 months	No
Secondary	Changes in levels of regulatory T cells		3 months	No