HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01266720

Enrollment

Registered

2010-12-24

Start date

2008-04-30

Completion date

2012-03-31

Last updated

2010-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer, peptide vaccine, VEGFR, gemcitabine

Brief summary

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.

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.

Interventions

BIOLOGICALVEGFR1, VEGFR2

One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22

DRUGGemcitabine

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Toxicities as assessed by NCI-CACAE ver3	3 months

Secondary

Measure	Time frame
CD8 population	3 months
Change in level of regulatory T cells	3 months
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration	3 months
Feasibility	1 year
Survival	1 year
Objective response rate	1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026