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Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

VEGFR1-1084, VEGFR2-169, and gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 PATIENTS CHARACTERISTICS

ECOG performance status 0-2
Life expectancy > 3 months
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
HLA-A*2402
Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Breast-feeder
Active or uncontrolled infection
Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
Serious or aggravated wound
Active or uncontrolled other malignancy
Steroids or immunosuppressing agent dependant status
Interstitial pneumonia
Ileus
Decision of unsuitableness by principal investigator or physician-in-charge

Sites / Locations

Fukushima Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase I study

Arm Description

Outcomes

Primary Outcome Measures

Adverse effect, toxicities as assessed by NCI CTCAE version3.0

Secondary Outcome Measures

feasibility

Full Information

NCT ID

NCT00639925

First Posted

March 7, 2008

Last Updated

March 13, 2013

Sponsor

Fukushima Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00639925

Brief Title

Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

Official Title

Phase I Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fukushima Medical University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase I study

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

VEGFR1-1084, VEGFR2-169, and gemcitabine

Intervention Description

One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8 and 15.

Primary Outcome Measure Information:

Title

Adverse effect, toxicities as assessed by NCI CTCAE version3.0

Time Frame

3 months

Secondary Outcome Measure Information:

Title

feasibility

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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 ECOG performance status 0-2 Life expectancy > 3 months 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 HLA-A*2402 Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breast-feeder Active or uncontrolled infection Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks Serious or aggravated wound Active or uncontrolled other malignancy Steroids or immunosuppressing agent dependant status Interstitial pneumonia Ileus Decision of unsuitableness by principal investigator or physician-in-charge

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitsukazu Gotoh, MD, PhD

Organizational Affiliation

Fukushima Medical University, First depertment of Surgery

Official's Role

Study Chair

Facility Information:

Facility Name

Fukushima Medical University Hospital

City

Fukushima

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

12415261

Citation

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.

Results Reference

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PubMed Identifier

17020992

Citation

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.

Results Reference

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PubMed Identifier

15930316

Citation

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.

Results Reference

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Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

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