A phase I study of cancer vaccine with CHP-MAGE-A4 in patients with advanced cancers expressing MAGE-A4 antige

Phase 1

• Conditions: Advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), colon cancer.

• Registration Number: JPRN-UMIN000003188
• Lead Sponsor: Department of Surgery Osaka University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-15
• Study Completion: 2014-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1.Other serious illnesses. 2.History of immunodeficiency disease or autoimmune disease. 3.Metastatic disease to the central nervous system, unless treated and stable. 4.Other malignancy 5.Known HIV, positivity. 6.Concomitant treatment with steroids. 7.Pregnancy or lactation. 8.Lack of availability of the patient for immunological and clinical follow-up assessment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. NY-ESO-1 specific immunity.

Secondary Outcome Measures

Name	Time	Method
Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).