Dendritic cell vaccination trial for hormone refractory prostate cancer with autologous tumour as the antige
Phase 1
Completed
- Conditions
- Hormone refractory prostate cancerCancer - 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
Name Time Method Safety assessed at each vaccination[Every two weeks for 10 weeks and then every 6 weeks for up to 1 year]
- Secondary Outcome Measures
Name Time Method 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.]