WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study

UMIN ID: UMIN000005248

Registered date:01/04/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 2011/05/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Combination therapy with GEM+WT1 vaccine 1) Gemcitabine: 1000mg/m2, day1, 8, 15, q28 intravenous injection, 30min. 2) WT1 peptide-based cancer vaccine: 3mg of WT1 peptide/body, day1, day15, q28 intradermal injection 2)-1 WT1 peptide mp235: HLA-A*2402 restricted WT1peptide or np126: HLA-A*0201 restricted WT1peptide 2)-2 Adjuvant Montanide ISA51
Gemcitabine alone 1) Gemcitabine: 1000mg/m2, day1, 8, 15, q28 intravenous injection, 30min.

Outcome(s)

• Primary Outcome: 1-year overall survival rate
• Secondary Outcome: Overall Survival(OS), 6-month OS rate, 1.5-year OS rate, Progression Free Survival, Disease control rate, Clinical benefit response, QOL, toxic effects, immunological monitoring, and non-immunological monitorings

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1) Simultaneous or metachronous (within 5 years) double cancers, with exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women fo childearing potential, and men who want to get partner pregnat 3) Psychosis 4) Patients requiring systemic immunosuppresive agents, or moderate or higher dose of steroid with exception of usage for cancer pain 5) Pulmonary fibrosis or interstitial pneumonitis 6) Active bacterial or fungal infection 7) Severe complications 8) MDS, MDS/MPD, MPD 9) Severe drug allergy 10) Inadequate physical condition, as diagnosed by the primary physician

Related Information

• Primary Sponsor: Department of Cancer Immunotherapy, Osaka university Graduate school of Medicine
• Secondary Sponsor: Dept. Surgery, Osaka Univ. graduate school of Med. Jikei University Tohoku Univ. graduate school of Med. Kansai Medical University Kyoto Prefectural Univ. Medicine Toho University Omori Medical center Kanagawa Cancer Center Sendai Open Hospital Teikyo University Hospital
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology