Know Cancer

or
forgot password

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


Phase 1
20 Years
80 Years
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.


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

PATIENT CHARACTERISTICS

1. ECOG performance status 0-2

2. Life expectancy > 3 months

3. Laboratory values as follows

- 2000/mm3 < WBC < 15000/mm3

- Platelet count > 75000/mm3

- Bilirubin < 3.0 mg/dl

- 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(woman of childbearing potential:Refusal or inability to use effective means
of contraception)

2. Breastfeeding

3. Active or uncontrolled infection

4. Concurrent treatment with steroids or immunosuppressing agent

5. Prior chemotherapy of gemcitabine

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

7. Serious or nonhealing wound, ulcer, or bone fracture

8. Active or uncontrolled other malignancy

9. Ileus

10. Interstitial pneumonia

11. 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:

Safety(toxicities as assessed by NCI CTCAE version 3)

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Hiroki Yamaue, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Wakayama Medical University, Second Department of Surgery

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

WPR2-0710

NCT ID:

NCT00622622

Start Date:

November 2006

Completion Date:

February 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location