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
Verified date | January 2009 |
Source | Tokyo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Research Hospital, The Institute of Medical Science, The University of Tokyo | Minato-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Tokyo University | Human Genome Center, Institute of Medical Science, University of Tokyo |
Japan,
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
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 |
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