A phase I clinical study of cancer vaccine with MAGE-A4/Survivin helper peptide for patients with advanced cancers expressing MAGE-A4 or Survivin antige

Phase 1

• Conditions: MAGE-A4- or Survivin-expressing refractory cancer patients (non origin-limited) or patients who refuse standard cancer therapy

• Registration Number: JPRN-UMIN000003489
• Lead Sponsor: Department of General Surgery, Hokkaido University Graduated School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-19
• Study Completion: 2012-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1) Pregnant women or refuse anticonception during the study (both sexes) 2) Lactating women 3) Severe bleeding disorders, meeting the criteria below; PT<50% APTT>60sec Fbg<100mg/dl FDP>20mg/ml 4) Active infection (HIV, HBV or HCV etc.) 5) Severe heart disease (NYHA class 3 or 4) 6) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.) 7) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics). 8) Patient with impaired mental status in the study. 9) Inappropriate for study entry judged by an attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: maximum tolerated dose, dose-limiting toxicity, profiles of adverse events evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.

Secondary Outcome Measures

Name	Time	Method
Efficacy: MAGE-A4 or Survivin-specific immune responses (Antibody production, Induction of antigen specific CD4+T and CD8+T cells), evaluated by ELISA or ELISPOT, and tumor responses, assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).