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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


Phase 1
20 Years
80 Years
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicities as assessed by NCI-CACAE ver3

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Mitsukazu Gotoh, MD & PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fukushima Medical University, Department of Regeneration Surgery

Authority:

Japan: Institutional Review Board

Study ID:

689

NCT ID:

NCT01266720

Start Date:

April 2008

Completion Date:

March 2012

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • peptide vaccine
  • VEGFR
  • gemcitabine
  • Pancreatic Neoplasms

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