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

Fukushima Medical University

Status and phase

Unknown

Phase 1

Conditions

Pancreatic Cancer

Treatments

Biological: VEGFR1, VEGFR2

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT01266720

689

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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