NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000004081

Registered date:21/08/2010

WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreatic and biliary tract cancers

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced pancreatic and biliary tract cancers
Date of first enrollment2010/07/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Administration of Gemcitabine: Gemcitabine(1000mg/m2)is administered via intravenous injection over 30min on day 1, 8, 15 of a 28-day cycle twice. WT1 vaccination: The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9-mer WT1 peptide (CYTWNQMNL) emulsified with Montanide ISA51 adjuvant over 1 hour after administration of gemsitabine. WT1 vaccine is performed every two weeks four times. Safty and efficacy are evaluated 7-14 days after fourth WT1 vaccination.

Outcome(s)

Primary OutcomeToxicities and adverse events are defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.
Secondary Outcome1. Climical response rate, Disease control rate, Clinical benefit response 2. QOL outcomes 3. Immune responses to WT1

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteriaDiagnosed as pancreatic or biliary tract cancer. 2. Informed about hisdiagnosis 3. 1) First-line treatment for inoperable patients. Stage IVa, IVb 2) Relase after operation Initial chemotherapy Two months after lastchemotherapy 4. HLA-A*2402 positive 5. Having evaluable disease by RECIST criteria 6. No chemotherapy/radiation/BRM has been performed. 7. Karnofsky Performance Status (KPS) over 50 8. Survival period is expected more than3 months 9. Meet the following criteria for organ functions 1)WBC more than4,000/microliter and less than 12,000,Neutrophil more than 2,000/microliter, Platelet moret han 100,000/microliter, Hemoglobin more than 9.5g/dl 2) Serum creatinine within normal limitation 3) Serum bilirubin less than1.5 folds of the upper normallimit 4) Serum AST/GOT less than 2.5 folds of the upper normallimit 5) Serum Albumin more than3.0g/dl 10. Pleural effusion, ascites and pericardial effusion are not detected orcontrolled. 11. Informed consent has been obtained
Exclude criteria1. There is deep-seated active infection. 2,3. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fibrosis, active interstitial pneumonitis. Patients who have complications that are considered inappropriate for the trial. 4. Dependent on total parenteral nutrition (TPN) 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodysplastic syndorome (MDS) and myeloproliferative disorders (MPD). 7. Pregnant or lactating woman 8. Past history of severe drug allergy 9. There is severe psychiatric disorder. 10. Responsible doctor's judged the patient inappropriate for the trial.

Related Information

Contact

public contact
Name Shigeo Koido
Address Japan
Telephone
E-mail shigeo_koido@jikei.ac.jp
Affiliation Jikei University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine
scientific contact
Name Haruo Sugiyama
Address 1-7, Yamada-oka, Suita City, Osaka , Japan Japan
Telephone
E-mail
Affiliation Osaka University Medical School Department of Clinical Laboratory Science