Phase I investigator initiated clinical trial using a novel WT1 peptide vaccine for patients with metastatic pancreatic cancer

Phase 1

• Conditions: pancreatic cancer

• Registration Number: JPRN-UMIN000029428
• Lead Sponsor: Wakayama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Interstitial pneumonia or pulmonary fibrosis (2) Comfirmed or suspicious brain metastatis (3) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage. (4) Severe infection or being suspected (5) Positive for serum HBs Ag or HBV-DNA (6) Positive for anti-HCV or anti-HIV ab (7) Patients who require systemic administration of Corticosteroid (8) Prior DSP-7888, other WT1 peptides, or WT1 immunotherapy (9) History of severe allergies to oil products (10) History of hypersensitivity to paclitaxel, albumin, and gemcitabine (11) Active another cancer to define the pprognosis (12) Severe mental disorders (13) Peripheral neuropathy >=CTCAE ver.4.0JCOG Grade 2 (14) Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease. (15)Myocardial infarction, severe unstable angina pectoris, colonary or peripheral artery bypass, congestive heart failure, cerebrovascular disease, pulmonary embolization, deep vein thrombosis or other severe thromboembolism within 12 months (16) Bleeding tendency or severe coagulation disorder (17) Current participation in other clinical trials. (18) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period. (19) The subject who was determined by investigator that being not adequate to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of DLT related to investigational drug.