HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-03-31

Brief Summary

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The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A\*0201 restricted patient with non-resectable pancreatic cancer.

Detailed Description

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The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.

Conditions

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Pancreatic Cancer

Keywords

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pancreatic cancer peptide vaccine VEGFR gemcitabine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 study

Interventions:

Biological: VEGFR1, VEGFR2 Drug: Gemcitabine

Group Type EXPERIMENTAL

VEGFR1, VEGFR2

Intervention Type BIOLOGICAL

One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Interventions

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VEGFR1, VEGFR2

One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22

Intervention Type BIOLOGICAL

Gemcitabine

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Intervention Type DRUG

Other Intervention Names

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VEGFR1 and VEGFR2 specific epitope vaccine Gemzar

Eligibility Criteria

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Inclusion Criteria

* locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
* Measurable disease by CT scan
* ECOG performance status 0-2
* Life expectancy \> 3 months
* laboratory values as follows: 2,000/mm3 \< WBC \< 15,000/mm3, Platelet count \>75,000/mm3, Total Bilirubin \<1.5 mg/dl, Asparate transaminase \<150IU/L, Alanine transaminase \< 150 IU/L, Creatinine \< 3.0mg/dl
* HLA-A\*0201
* Able and willing to give valid written infromed 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 uncured wound
* Active or uncontrolled other malignancy
* Steroids or immunosuppressing agent dependent status
* Interstitial pneumonia
* Ileus
* 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

Responsible Party

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Fukushima Medical University

Principal Investigators

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Mitsukazu Gotoh, MD & PhD

Role: STUDY_CHAIR

Fukushima Medical University, Department of Regeneration Surgery

Locations

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Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Site Status

Countries

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Japan

References

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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

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689

Identifier Type: -

Identifier Source: org_study_id

HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Phase 1 study

VEGFR1, VEGFR2

Gemcitabine

Interventions

VEGFR1, VEGFR2

Gemcitabine

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Fukushima Medical University

Responsible Party

Principal Investigators

Mitsukazu Gotoh, MD & PhD

Locations

Fukushima Medical University Hospital

Countries

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.

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.

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.

Other Identifiers

689