Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: VEGFR2-169 and gemcitabine

• Registration Number: NCT00622622
• Lead Sponsor: Wakayama Medical University

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.

Detailed Description

Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A\*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A\*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2006-12
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-25
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

PATIENT CHARACTERISTICS

1. ECOG performance status 0-2

2. Life expectancy > 3 months

3. Laboratory values as follows

   • 2000/mm3 < WBC < 15000/mm3
   • Platelet count > 75000/mm3
   • Bilirubin < 3.0 mg/dl
   • 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(woman of childbearing potential:Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Active or uncontrolled infection
4. Concurrent treatment with steroids or immunosuppressing agent
5. Prior chemotherapy of gemcitabine
6. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
7. Serious or nonhealing wound, ulcer, or bone fracture
8. Active or uncontrolled other malignancy
9. Ileus
10. Interstitial pneumonia
11. 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 I study	VEGFR2-169 and gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Safety(toxicities as assessed by NCI CTCAE version 3)	3 months

Secondary Outcome Measures

Name	Time	Method
VEGFR2 peptide specific CTL induction in vitro	3 months
DTH to VEGFR2 peptide	3 months
Changes in levels of regulatory T cells	3 months
Objective response rate as assessed by RECIST criteria	1 year
Time to progression	1 years
survival	1 years

Trial Locations

Locations (1)

Wakayama Medical University Hospital; 🇯🇵 811-1 Kimiidera, Wakayama, Wakayama, Japan