Multiple-Vaccine Therapy in Treating Patients With Non-small Cell Lung Cancer

NCT ID: NCT00633724

Last Updated: 2013-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-06-30

Brief 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, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Detailed Description

URLC10 and TTK 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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2

Intervention Type: BIOLOGICAL

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 0.5mg, 1.0mg and 3.0mg.

Interventions

HLA-A*2402restricted URLC10, TTK, 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 0.5mg, 1.0mg and 3.0mg.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Human Genome Center, Institute of Medical Science, University of Tokyo

OTHER

Sponsor Role: collaborator

Fukushima Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hiroyuki Suzuki

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitsukazu Gotoh, MD,PhD

Role: STUDY_CHAIR

Fukushima Medical University, First department of Surgery

Locations

Fukushima Medical University Hospital

Fukushima, Fuskushima, Japan

Countries

Japan

References

Suda T, Tsunoda T, Uchida N, Watanabe T, Hasegawa S, Satoh S, Ohgi S, Furukawa Y, Nakamura Y, Tahara H. Identification of secernin 1 as a novel immunotherapy target for gastric cancer using the expression profiles of cDNA microarray. Cancer Sci. 2006 May;97(5):411-9. doi: 10.1111/j.1349-7006.2006.00194.x.

Reference Type: BACKGROUND

PMID: 16630140 (View on PubMed)

Uchida N, Tsunoda T, Wada S, Furukawa Y, Nakamura Y, Tahara H. Ring finger protein 43 as a new target for cancer immunotherapy. Clin Cancer Res. 2004 Dec 15;10(24):8577-86. doi: 10.1158/1078-0432.CCR-04-0104.

Reference Type: BACKGROUND

PMID: 15623641 (View on PubMed)

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. doi: 10.1158/1078-0432.CCR-06-0750.

Reference Type: BACKGROUND

PMID: 17020992 (View on PubMed)

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. doi: 10.1158/0008-5472.CAN-04-3759.

Reference Type: BACKGROUND

PMID: 15930316 (View on PubMed)

Watanabe T, Suda T, Tsunoda T, Uchida N, Ura K, Kato T, Hasegawa S, Satoh S, Ohgi S, Tahara H, Furukawa Y, Nakamura Y. Identification of immunoglobulin superfamily 11 (IGSF11) as a novel target for cancer immunotherapy of gastrointestinal and hepatocellular carcinomas. Cancer Sci. 2005 Aug;96(8):498-506. doi: 10.1111/j.1349-7006.2005.00073.x.

Reference Type: BACKGROUND

PMID: 16108831 (View on PubMed)

Suzuki H, Fukuhara M, Yamaura T, Mutoh S, Okabe N, Yaginuma H, Hasegawa T, Yonechi A, Osugi J, Hoshino M, Kimura T, Higuchi M, Shio Y, Ise K, Takeda K, Gotoh M. Multiple therapeutic peptide vaccines consisting of combined novel cancer testis antigens and anti-angiogenic peptides for patients with non-small cell lung cancer. J Transl Med. 2013 Apr 11;11:97. doi: 10.1186/1479-5876-11-97.

Reference Type: DERIVED

PMID: 23578144 (View on PubMed)

Other Identifiers

FVT-L0701

Identifier Type: -

Identifier Source: org_study_id