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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: VEGFR1-1084, VEGFR2-169; Drug: Gemcitabine

• Registration Number: NCT00655785
• Lead Sponsor: Fukushima Medical University

Brief 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

Detailed 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

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1/2 study	VEGFR1-1084, VEGFR2-169	-
Phase 1/2 study	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
toxicities as assessed by NCI-CACAE ver3)	3 months

Secondary Outcome Measures

Name	Time	Method
Objective response rate	1year
feasibility	1year
Survival	1year
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration	3months
CD8 population	3months
Change in level of regulatory T cells	3months

Trial Locations

Locations (1)

Fukushima Medical University Hospital; 🇯🇵 Fukushima, Japan