Know Cancer

or
forgot password

Phase I/Ⅱ 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


Phase 1/Phase 2
20 Years
80 Years
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase I/Ⅱ 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


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


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

1. ECOG performance status 0-2

2. Life expectancy > 3 months

3. 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

4. HLA-A*2402

5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective
means of contraception)

2. Breast-feeder

3. Active or uncontrolled infection

4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks

5. Serious or uncured wound

6. Active or uncontrolled other malignancy

7. Steroids or immunosuppressing agent dependent status

8. Interstitial pneumonia

9. Ileus

10. Decision of unsuitableness by principal investigator or physician-in-charge

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy 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, M.D. & Ph.D

Investigator Role:

Study Chair

Investigator Affiliation:

Fukushima Medical University, Department

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

FPCR1R2-2

NCT ID:

NCT00655785

Start Date:

September 2007

Completion Date:

March 2013

Related Keywords:

  • Pancreatic Cancer
  • Epitope peptide
  • CTL
  • Pancreatic cancer
  • Vaccination VEGFR1
  • VEGFR2
  • Pancreatic Neoplasms

Name

Location