NIPH Clinical Trials Search

UMIN ID: UMIN000001187

Registered date:20/06/2008

WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreas cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpancreas cancer
Date of first enrollment2008/03/01
Target sample size18
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 .


Primary OutcomeSafety
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 criteria
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 fiblosis, 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 myelodisplastic 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 doctors judged the patient inappropriate for the trial

Related Information


public contact
Name Sumiyuki Nishida
Address 2-2, Yamada-oka, Suita City, Osaka, Japan Japan
Telephone 06-6879-3676
Affiliation Osaka University Medical School Department of Cancer Immunotherapy
scientific contact
Name Haruo Sugiyama
Address 1-7, Yamada-oka, Suita City, Osaka , Japan Japan
Telephone 06-6879-2593
Affiliation Osaka University Medical School Department of Clinical Laboratory Science