Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against malignant bone and soft tissue tumors: A phase I/II study

Phase 1

• Conditions: Malignant bone and soft tissue tumors

• Registration Number: JPRN-UMIN000010257
• Lead Sponsor: Department of Orthopaedic Surgery, Kochi Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-18
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with uncontrollable infectious diseases (including active Tuberculosis). 2) Patients with severe complications(malignant hypertension, severe congestive heart failure, severe colonary insufficiency, myocardial, infarction within three months, terminal stage of liver cirrhosis, uncontrollable diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonitis, etc.). 3) Patients after allogeneic bone marrow transplantation. 4) Pregnant or breast-feeding women. 5) Patients with severe psychiatric diseases. 6) Patients who have participate in any other clinical trial. 7) Patients who have previously participated in this clinical trial. 8) Any patients disqualified by a study physician because of medical, psychological, or any other reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of side effects(Phase I) Progression-free survival(Phase II)

Secondary Outcome Measures

Name	Time	Method
Disease control rate, survival rate, local control rate, overall survival, adverse events, immunological responses