HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01266720
• Other study ID #: 689
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 23, 2010
• Last updated: December 23, 2010
• Start date: April 2008
• Est. completion date: March 2012

Study information

• Verified date: December 2010
• Source: Fukushima Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: March 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• VEGFR1, VEGFR2
One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22

Drug:
• Gemcitabine
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Locations

Country	Name	City	State
Japan	Fukushima Medical University Hospital	Fukushima

Sponsors (2)

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

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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

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. Epub 2002 Nov 4. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities as assessed by NCI-CACAE ver3		3 months	Yes
Secondary	Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration		3 months	No
Secondary	CD8 population		3 months	No
Secondary	Change in level of regulatory T cells		3 months	No
Secondary	Objective response rate		1 year	No
Secondary	Feasibility		1 year	No
Secondary	Survival		1 year	No

External Links

•   Fukushima Medical University (Department of Regeneration Surgery)