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

NCT00633724 | Completed Phase 1 DMC

• 1 other identifier: FVT-L0701
• 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 response of different doses of HLA-A\*2402 restricted epitope peptides URLC10, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Peptides specific CTL responses in vitro

  3 months

• Objective response rate as assessed using RECIST criteria

  6 months

• Changes in levels of regulatory T cells

  3 months

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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

1

Eligibility Criteria

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

You may qualify if:

• Disease characteristics
• Advanced or recurrent non small cell lung cancer
• Second line or later therapeutic status
• Patient characteristics
• ECOG performance status 0-2
• Life expectancy \> 3 months
• HLA-A\*2402
• 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
• Able and willing to give valid written informed consent

You may not qualify if:

• Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
• Pregnancy (woman of child bearing potential)
• Active and uncontrolled infectious disease
• Adrenal cortical steroid hormone dependent status
• Decision of unsuitableness by principal investigator

Sponsors & Collaborators

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

Study Sites (1)

Fukushima Medical University Hospital

Fukushima, Fuskushima, 960-1295, Japan

Location

Related Publications (6)

• 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.

  PMID: 16630140 BACKGROUND

• 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.

  PMID: 15623641 BACKGROUND

• 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.

  PMID: 17020992 BACKGROUND

• 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.

  PMID: 15930316 BACKGROUND

• 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.

  PMID: 16108831 BACKGROUND

• 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.

  PMID: 23578144 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Mitsukazu Gotoh, MD,PhD

  Fukushima Medical University, First department of Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: March 12, 2008
• Study Start: May 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

JP (1)