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

Thank you

Trial Information

Phase I 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 aggravated wound

6. Active or uncontrolled other malignancy

7. Steroids or immunosuppressing agent dependant 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 Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse effect, toxicities as assessed by NCI CTCAE version3.0

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Mitsukazu Gotoh, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fukushima Medical University, First depertment of Surgery

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

FPCR1R2-1

NCT ID:

NCT00639925

Start Date:

March 2007

Completion Date:

March 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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