HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fukushima Medical University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Fukushima Medical University
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Fukushima Medical University
ClinicalTrials.gov Identifier:
NCT01266720
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Biological: VEGFR1, VEGFR2 Drug: Gemcitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by Fukushima Medical University:
Primary Outcome Measures:
- Toxicities as assessed by NCI-CACAE ver3 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- CD8 population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Change in level of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Objective response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase 1 study
Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine |
Biological: VEGFR1, VEGFR2
One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22
Other Name: VEGFR1 and VEGFR2 specific epitope vaccine
Drug: Gemcitabine
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.
Other Name: Gemzar
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266720
Locations
| Japan | |
| Fukushima Medical University Hospital | |
| Fukushima, Japan, 960-1295 | |
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
| Study Chair: | Mitsukazu Gotoh, MD & PhD | Fukushima Medical University, Department of Regeneration Surgery |
More Information
Additional Information:
Publications:
| Responsible Party: | Fukushima Medical University (Department of Regeneration Surgery), Fukushima Medical University |
| ClinicalTrials.gov Identifier: | NCT01266720 History of Changes |
| Other Study ID Numbers: | 689 |
| Study First Received: | December 23, 2010 |
| Last Updated: | December 23, 2010 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Fukushima Medical University:
|
pancreatic cancer peptide vaccine VEGFR gemcitabine |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013