- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00639925
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer
March 13, 2013 updated by: Takashi Kimura, Fukushima Medical University
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
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Fukushima, Japan
- Fukushima Medical University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase I study
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse effect, toxicities as assessed by NCI CTCAE version3.0
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
feasibility
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mitsukazu Gotoh, MD, PhD, Fukushima Medical University, First depertment of Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Anticipated)
March 1, 2013
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
March 7, 2008
First Submitted That Met QC Criteria
March 19, 2008
First Posted (Estimate)
March 20, 2008
Study Record Updates
Last Update Posted (Estimate)
March 14, 2013
Last Update Submitted That Met QC Criteria
March 13, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- FPCR1R2-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Recurrent Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
Shanghai Zhongshan HospitalFudan UniversityNot yet recruitingPancreatic Cancer Stage III | Pancreatic Cancer, Stage IB | Pancreatic Cancer, Stage IIA | Pancreatic Cancer, Stage IIBChina
-
University of Wisconsin, MadisonCompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
Clinical Trials on VEGFR1-1084, VEGFR2-169, and gemcitabine
-
Fukushima Medical UniversityHuman Genome Center, Institute of Medical Science, University of TokyoCompleted
-
Osaka UniversityHuman Genome Center, Institute of Medical Science, University of TokyoCompletedAge Related Macular Degeneration | Neovascular MaculopathyJapan
-
Japanese Foundation for Cancer ResearchHuman Genome Center, Institute of Medical Science, University of TokyoCompleted
-
Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of TokyoCompleted
-
Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of TokyoTerminated
-
Fukushima Medical UniversityHuman Genome Center, Institute of Medical Science, University of TokyoUnknown
-
Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of TokyoCompleted
-
Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of TokyoUnknownNon Small Cell Lung CancerJapan
-
Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of TokyoCompleted
-
Tokyo UniversityHuman Genome Center, Institute of Medical Science, University of TokyoUnknownPancreatic Cancer | Pancreas NeoplasmsJapan