Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Urothelial Cancer (Phase I clinical study)

Phase 1

• Conditions: Advanced or recurrent urothelial cancer

• Registration Number: JPRN-UMIN000001499
• Lead Sponsor: Department of Urology, Sapporo Medical University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-11
• Study Completion: 2009-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria included (1) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the previous 4 weeks, (2) the presence of other cancers that might influence the prognosis, (3) immunodeficiency or a history of splenectomy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure and (5) unsuitability for the trial based on clinical judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of adverse effect

Secondary Outcome Measures

Name	Time	Method
Evaluation of immunological and clinical responses. Immunological responses are investigated by DTH, tetramer staining, and ELISPOT assay. Clinical responses are evaluated by RECIST criteria.