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Phase II clinical study of HLA-A*2402-restricted survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer

Phase II clinical study of HLA-A*2402-restricted survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer - Phase II study of survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005819
Enrollment
20
Registered
2011-06-21
Start date
2009-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer

Interventions

Sponsors

Sapporo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed urothelial carcinoma 2) Ta or T1 N0 M0 bladder cancer 3) Survivin-expressing tumor 4) HLA-A*2402 5) ECOG PS (Performance Status) 0-3 6) No organ failure (WBC >= 3000 cells/mm3, Hemoglobin >= 8.0 g/d, Platelet >= 10x10e4/mm3, Serum creatinine <= 2.0, Total bilirubin <=1.5, AST and ALT <= 2 x ULN 7) No previous chemotherapy, immunotherapy or radiotherapy within a month 8) Signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment

Exclusion criteria

Exclusion criteria: 1) Coexistence of other malignancy 2) Immunodeficiency or history of splenectomy 3) Intake of steroids or immunosuppressants 4) Severe heart disease, active infection, coagulation disorder 5) Under anticoagulant therapy 6) Pregnant woman 7) Lactating woman 8) Hope to have a children 9) No willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures 10) History of severe drug allergy 11) History of severe drug-induced hepatic or renal dysfunction

Design outcomes

Secondary

MeasureTime frame
Induction of epitope-specific T cell immunity

Primary

MeasureTime frame
Recurrence-free survival

Countries

Japan

Contacts

Public ContactToshihiro Maeda

Sapporo Medical University School of Medicine Department of Urology

maeda-t@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026