Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00622622 |
Recruitment Status
:
Completed
First Posted
: February 25, 2008
Last Update Posted
: February 18, 2009
|
Sponsor:
Wakayama Medical University
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Wakayama Medical University
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 13, 2008 | |||
First Posted Date ICMJE | February 25, 2008 | |||
Last Update Posted Date | February 18, 2009 | |||
Study Start Date ICMJE | November 2006 | |||
Actual Primary Completion Date | December 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety(toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 3 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00622622 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Pancreatic Cancer | |||
Intervention ICMJE | 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. |
|||
Study Arms | Experimental: Phase I study
Intervention: Biological: VEGFR2-169 and gemcitabine |
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
21 | |||
Original Estimated Enrollment ICMJE |
18 | |||
Actual Study Completion Date | February 2009 | |||
Actual Primary Completion Date | December 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: DISEASE CHARACTERISTICS
PATIENT CHARACTERISTICS
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 20 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00622622 | |||
Other Study ID Numbers ICMJE | WPR2-0710 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Second Department of Surgery, Wakayama Medical University | |||
Study Sponsor ICMJE | Wakayama Medical University | |||
Collaborators ICMJE | Human Genome Center, Institute of Medical Science, University of Tokyo | |||
Investigators ICMJE |
|
|||
PRS Account | Wakayama Medical University | |||
Verification Date | February 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |