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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fukushima Medical University
• Collaborator: Human Genome Center, Institute of Medical Science, University of Tokyo
• Treatments: Angiogenesis Inhibitors; Gemcitabine

Criteria

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