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

Pancreatic Cancer Clinical Trial

Official title:

Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00683358
• Other study ID #: IMSUT-PPKVEGFR12402
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: May 16, 2008
• Last updated: May 6, 2009
• Start date: May 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2009
• Source: Tokyo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.

These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 14
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pancreas Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• VEGFR1-A24-1084 (SYGVLLWEI)
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.

Locations

Country	Name	City	State
Japan	Research Hospital, The Institute of Medical Science, The University of Tokyo	Minato-ku	Tokyo

Sponsors (2)

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

Country where clinical trial is conducted

Japan, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase?; safety (NCI CTCAE v.3) Phase?;time to progression (RECIST)		1 year
Secondary	Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)		1 year
Secondary	Tumor regression(Imaging study, tumor marker, etc.)		1 year

External Links

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