Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

NCT00683358 | Unknown Phase 1 DMC

• 1 other identifier: IMSUT-PPKVEGFR12402
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients. Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively. HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

Conditions

Pancreatic Cancer; Pancreas Neoplasms

Keywords

cancer; pancreas; advanced; peptide; vaccination; VEGFR1; HLA; gemcitabine; IFA; Cancer of Pancreas; Neoplasms, Pancreatic; Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)

  1 year

Secondary Outcomes (2)

• Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)

  1 year

• Tumor regression(Imaging study, tumor marker, etc.)

  1 year

Study Arms (1)

1

EXPERIMENTAL

Biological: VEGFR1-A24-1084 (SYGVLLWEI)

Interventions

VEGFR1-A24-1084 (SYGVLLWEI) BIOLOGICAL

HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.

Also known as: HLA-A*2402, advanced pancreatic cancer, VEGFR1, VEGFR1-A24-1084, SYGVLLWEI, IFA, Montanide ISA51

1

Eligibility Criteria

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

You may qualify if:

• Heterozygote or homozygote of HLA-A\*2402 allele
• Inoperable or recurrent pancreatic cancer with or without any prior therapy
• Difficult to continue the prior therapy due to treatment-related toxicities
• ECOG performance status 0-2
• Evaluable primary or metastatic lesion with RECIST criteria
• Clearance period from prior therapy more than 4 weeks
• Life expectancy more than 3 months
• Laboratory values as follows 2,000/μL\<WBC\<15,000/μL Platelet count\>100,000/μL AST\<150IU/L ALT\<150IU/L Total bilirubin\<3.0mg/dl Serum creatinine\<3.0mg/dl

You may not qualify if:

• Pregnancy (refusal or inability to use effective contraceptives)
• Breastfeeding
• Active or uncontrolled infection
• Systemic use of corticosteroids or immunosuppressants
• Uncontrollable brain metastasis and/or meningeal infiltration
• Unhealed external wound
• Possibilities of complicated paralytic ileus or interstitial pneumonitis
• Decision of not eligible determined by principal investigator or attending doctor

Sponsors & Collaborators

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

Study Sites (1)

Research Hospital, The Institute of Medical Science, The University of Tokyo

Minato-ku, Tokyo, 108-8639, Japan

Location

Related Publications (2)

• 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

• Nagayama H, Sato K, Morishita M, Uchimaru K, Oyaizu N, Inazawa T, Yamasaki T, Enomoto M, Nakaoka T, Nakamura T, Maekawa T, Yamamoto A, Shimada S, Saida T, Kawakami Y, Asano S, Tani K, Takahashi TA, Yamashita N. Results of a phase I clinical study using autologous tumour lysate-pulsed monocyte-derived mature dendritic cell vaccinations for stage IV malignant melanoma patients combined with low dose interleukin-2. Melanoma Res. 2003 Oct;13(5):521-30. doi: 10.1097/00008390-200310000-00011.

  PMID: 14512794 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

HLA-A*24:02 antigen; Receptor Protein-Tyrosine Kinases; montanide ISA 51

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System 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

• Naohide Yamashita, MD, PhD

  Director, Research Hospital, Institute of Medical Science, Tokyo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 7, 2009

Record last verified: 2009-01

Locations

JP (1)