Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer

Wakayama Medical University

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Biological: VEGFR2-169 and gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00622622

WPR2-0710

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Phase I study

Experimental group

Treatment:

Biological: VEGFR2-169 and gemcitabine