Phase I pilot study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with gemcitabine for patients with advanced pancreatic cancer

Phase 1

• Conditions: unresectable pancreatic cancer

• Registration Number: JPRN-UMIN000004855
• Lead Sponsor: School of Medicine, Keio University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-15
• Study Completion: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1)Active other primary malignancies 2)Past history of severe allergy 3)Severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes) 4)Pleural effusion or pericardial fluid requiring treatment 5)Pregnancy, nursing women 6)Male hope to impregnate 7)Carrier of HBV, HTLV-1, HIV and so on 8)Severe psychiatric disease 9)Symptomatic interstitial pneumonia or fibroid lung that be diagnosed by X-ray 10)Past history of autoimmune disease 11)During treatment with immunosuppressive agents 12)Patients whom doctors judged inadequate to the enrollment of this study by other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events

Secondary Outcome Measures

Name	Time	Method
Response rate Progression free survival Overall survival Immune induction (Delayed type hypersensensitivity DTH for WT1 peptide)