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

NCT ID: NCT00655785

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2013-03-31

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

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1/2 study

Group Type: EXPERIMENTAL

VEGFR1-1084, VEGFR2-169

Intervention Type: BIOLOGICAL

One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C

Gemcitabine

Intervention Type: DRUG

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

Interventions

VEGFR1-1084, VEGFR2-169

One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C

Intervention Type: BIOLOGICAL

Gemcitabine

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Human Genome Center, Institute of Medical Science, University of Tokyo

OTHER

Sponsor Role: collaborator

Fukushima Medical University

OTHER

Sponsor Role: lead

Responsible Party

Takashi Kimura

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitsukazu Gotoh, M.D. & Ph.D

Role: STUDY_CHAIR

Fukushima Medical University, Department

Locations

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Countries

Japan

References

Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.

Reference Type: BACKGROUND

PMID: 12415261 (View on PubMed)

Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.

Reference Type: BACKGROUND

PMID: 17020992 (View on PubMed)

Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.

Reference Type: BACKGROUND

PMID: 15930316 (View on PubMed)

Other Identifiers

FPCR1R2-2

Identifier Type: -

Identifier Source: org_study_id