None listed
Conditions
Brief summary
Phase 1 This is a trial of an anti-cancer treatment known as BDCA-BDC-01 which is a preparation of blood dendritic cells (BDC-1 type) loaded with antigens. The treatment is for immune therapy of distant secondary cancer (metastases) of the prostate when this no longer responds to hormone treatment (hormone-refractory). Who is it for? You can take part in this trial if you have distant secondary prostate cancer which has not responded to androgen deprivation therapy (therapy to reduce levels of the hormone testosterone in your body). Trial details Participants receive injections either under the skin or intravenously with a BDC-1 blood dendritic cell preparation which is loaded with special proteins (antigens that prompt the formation of antibodies). This happens once a month for 3 months. The trial aims to induce an immune response against the cancer and assess the safety and effectiveness of this treatment. Dendritic cells are important immune cells which are normally present in the human body. BDC-1 dendritic cells are a type of dendritic cell. Dendritic cells can be prepared with special proteins from the prostate cancer to enhance the immune response. The standard treatment for metastatic prostate cancer that is not responding to androgen deprivation is chemotherapy.
Interventions
A BDC-1+ blood dendritic cell preparation loaded with control and tumour associated antigens given either intradermally or intravenously once a month for 3 months.
Sponsors
Mater Medical Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Metastatic, androgen independent adenocarcinoma, histologically documented of the prostate. Adequate androgen suppression. HLA-A*0201 positive. Life expectancy of at least 6 months. Performance status ECOG less than or equal to 2.
Exclusion criteria
Intercurrent participation in another clinical trial for prostate cancer theray. Known brain metastases, spinal cord compression of vertebral metastases with risk of spinal cord compression. Progressive metastatic disease, as defined as increasing symptoms requiring change in medication within the previous 4 weeks. Treatment with chemotherapy, bisphosphonate therapy, external beam radiation therapy, surgery, systemic corticosteroids, megestrol acetate, DES, ketoconazole, 5-alpha-reductase inhibitors, calcitriol, IFN-alpha or other immunomodulatory medication, or any other systemic therapy for prostate cancer within 28 days of registration (excluding androgen deprivation therapy). Receipt of investigational vaccine within 1 year of registration. Receipt of any other investigational product within 28 days of registration. Known pathological long-bone fractures, or imminent pathological long-bone fractures. Antibiotic therapy or infection within 1 week prior to registration, including unexplained fever. No vaccinations against infectious disease, including influenza vaccine in the three months prior to and during the trial. Intercurrent medical, surgical or psychiatric condition, which, in the opinion of the medical monitor, may interfere with the conduct and safety of the trial. Positivity for HIV I/II, HTLV I/II, Hepatitis B or C or Syphilis.
Outcome results
None listed