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Sponsors and Collaborators: |
Wakayama Medical University Human Genome Center, Institute of Medical Science, University of Tokyo |
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Information provided by: | Wakayama Medical University |
ClinicalTrials.gov Identifier: | NCT00622622 |
The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Biological: VEGFR2-169 and gemcitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase I Study of Gemcitabine With Antiangiogenic Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 Derived From VEGFR2 in Patients With Unresectable, Locally Advanced, Recurrent or Metastatic Pancreatic Cancer |
Enrollment: | 21 |
Study Start Date: | November 2006 |
Study Completion Date: | February 2009 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase I study: Experimental |
Biological: VEGFR2-169 and gemcitabine
Escalating doses of VEGFR2-169 will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles(doses of 0.5,1.0,2.0mg/body are planned). Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days 1,8 and 15. Repeated cycles of VEGFR2-169 and gemcitabine will be administered until patients develop progressive disease or unacceptable toxicity,or for maximum 2 cycles, whichever occurs first.
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Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
DISEASE CHARACTERISTICS
PATIENT CHARACTERISTICS
Laboratory values as follows
Exclusion Criteria:
Japan, Wakayama | |
Wakayama Medical University Hospital | |
811-1 Kimiidera, Wakayama, Wakayama, Japan |
Study Chair: | Hiroki Yamaue, MD | Wakayama Medical University, Second Department of Surgery |
Responsible Party: | Wakayama Medical University ( Second Department of Surgery ) |
Study ID Numbers: | WPR2-0710 |
Study First Received: | February 13, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00622622 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents |
Recurrence Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Gemcitabine |
Endocrine Gland Neoplasms Digestive System Neoplasms Growth Substances Endocrine System Diseases Enzyme Inhibitors Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |