Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	20 to 80	Other	FPCR1R2-2 NCT00655785

Trial Description

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

Further Study Information

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

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Fukushima Medical University Hospital

Mitsukazu Gotoh

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00655785
Information obtained from ClinicalTrials.gov on March 18, 2009