Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)

Pancreatic Cancer Clinical Trial

Official title:

Phase Ｉ/Ⅱ Sturdy on Antiangiogenic 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: Completed

Administrative data

• NCT number: NCT00655785
• Other study ID #: FPCR1R2-2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 4, 2008
• Last updated: March 13, 2013
• Start date: September 2007
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Fukushima Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Description:

Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

DISEASE CHARACTERISTICS

1. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer

2. Measurable disease by CT scan

PATIENTS CHARACTERISTICS

1. ECOG performance status 0-2

2. Life expectancy > 3 months

3. Laboratory values as follows:

• 2,000/mm3 < WBC < 15000/mm3

• Platelet count = 750,000/mm³

• Total Bilirubin = 1.5 x

• Aspartate transaminase < 150 IU/L

• Alanine transaminase < 150 IU/L

• Creatinine = 3.0 mg/dl

4. HLA-A*2402

5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)

2. Breast-feeder

3. Active or uncontrolled infection

4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks

5. Serious or uncured wound

6. Active or uncontrolled other malignancy

7. Steroids or immunosuppressing agent dependent status

8. Interstitial pneumonia

9. Ileus

10. Decision of unsuitableness by principal investigator or physician-in-charge

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• VEGFR1-1084, VEGFR2-169
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C

Drug:
• Gemcitabine
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

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		3months	No
Secondary	CD8 population		3months	No
Secondary	Change in level of regulatory T cells		3months	No
Secondary	Objective response rate		1year	No
Secondary	feasibility		1year	No
Secondary	Survival		1year	No