MedPath

Dendritic cell vaccination trial for hormone refractory prostate cancer with autologous tumour as the antige

Phase 1
Completed
Conditions
Hormone refractory prostate cancer
Cancer - Prostate
Registration Number
ACTRN12605000424606
Lead Sponsor
Queensland Institute of Medical Research (QIMR)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Male
Target Recruitment
20
Inclusion Criteria

Histologically proven prostatic Cancer, Maintenance hormone monotherapy, Serum PSA titres rising on 2 consecutive analyses, Minimum 5g of tumour-containing tissue.

Exclusion Criteria

ECOG status >1, Significantly abnormal Haematological parameters, History of autoimmune disease or previous long-term use of immunosuppressive therapy, Positive serology for HIV, Hep C or B, Significant non-malignant disease, Psychiatric, addictive or any conditions which compromise ability to participate in trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety assessed at each vaccination[Every two weeks for 10 weeks and then every 6 weeks for up to 1 year]
Secondary Outcome Measures
NameTimeMethod
PSA levels tested at each vaccination[Every two weeks for 10 weeks and then every 6 weeks for up to 1 year.];Tumour stasis/regression assessed by radiography performed either.[At final assessment or as clinically indicated based on PSA levels.]
© Copyright 2025. All Rights Reserved by MedPath