Clinical trial NCT01266720: HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)
Official title: Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
peptide vaccine
VEGFR
gemcitabine
Lead sponsor: Fukushima Medical University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2010-12-24
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A\*0201 restricted patient with non-resectable pancreatic cancer.

Detailed description: The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.

Eligibility criteria: Inclusion Criteria:

* locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
* Measurable disease by CT scan
* ECOG performance status 0-2
* Life expectancy \> 3 months
* laboratory values as follows: 2,000/mm3 \< WBC \< 15,000/mm3, Platelet count \>75,000/mm3, Total Bilirubin \<1.5 mg/dl, Asparate transaminase \<150IU/L, Alanine transaminase \< 150 IU/L, Creatinine \< 3.0mg/dl
* HLA-A\*0201
* Able and willing to give valid written infromed consent

Exclusion Criteria:

* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
* Breast-feeder
* Active or uncontrolled infection
* Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
* Serious or uncured wound
* Active or uncontrolled other malignancy
* Steroids or immunosuppressing agent dependent status
* Interstitial pneumonia
* Ileus
* Decision of unsuitableness by principal investigator or physician-in-charge

Primary outcomes:
measure: Toxicities as assessed by NCI-CACAE ver3
timeFrame: 3 months
Secondary outcomes:
measure: Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
timeFrame: 3 months
measure: CD8 population
timeFrame: 3 months
measure: Change in level of regulatory T cells
timeFrame: 3 months
measure: Objective response rate
timeFrame: 1 year
measure: Feasibility
timeFrame: 1 year
measure: Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
Study officials:
affiliation: Fukushima Medical University, Department of Regeneration Surgery
name: Mitsukazu Gotoh, MD & PhD
role: STUDY_CHAIR
References:
citation: Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.
citation: 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.
citation: 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.