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Trial registered on ANZCTR
Registration number
ACTRN12605000130662
Ethics application status
Approved
Date submitted
8/08/2005
Date registered
12/08/2005
Date last updated
17/04/2009
Type of registration
Prospectively registered
Titles & IDs
Public title
A phase 1 clinical trial of BDCA-BDC-01, a BDC-1 blood dendritic cell preparation loaded with control and tumour-associated antigens to evaluate the safety of immune therapy in metastatic hormone refractory prostate cancer
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Scientific title
A phase 1 clinical trial of BDCA-BDC-01, a BDC-1 blood dendritic cell preparation loaded with control and tumour-associated antigens to evaluate the safety of immune therapy in metastatic hormone refractory prostate cancer
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Secondary ID [1]
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Mater Medical Research Institute (MMRI): CT2-PC-BDCA-1BDC-01
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Universal Trial Number (UTN)
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Trial acronym
MMRI#CT2-PC-BDCA-1BDC-01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic hormone refractory prostate cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
134
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Treatment: Other
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Comparator / control treatment
No compartor/control treatment
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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This study has been designed prinicpally to assess the safety of BDCA-1BDC-01 in patients with metastatic hormone refractory prostate cancer
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Assessment method [1]
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Timepoint [1]
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End of Study 5.5 months
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Secondary outcome [1]
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To evaluate the preliminary efficacy of the vaccine in the induction of an immune response against metastatic hormone refractory prostate cancer after 3 vaccinates.
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Assessment method [1]
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Timepoint [1]
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End of Study 5.5 months
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Secondary outcome [2]
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The evaluation of the disease response to the 3 vaccines in patients with metastatic hormone refractory prostate cancer.
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Assessment method [2]
649
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Timepoint [2]
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End of Study 5.5 months
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Eligibility
Key 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.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/12/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Mater Medical Research Institute
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Address [1]
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Level 3 Aubigny Place
Raymond Terrace
South Brisbane Q 4101
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Mater Foundation
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Address [2]
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Mater Health Services
Raymond Terrace
South Brisbane Qld 4101
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Country [2]
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Australia
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Primary sponsor type
Other
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Name
Mater Medical Research Institute
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Address
Level 3 Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
236
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Country [1]
236
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Mater Health Services
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
1174
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Approval date [1]
1174
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Ethics approval number [1]
1174
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Professor Derek Hart
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Address
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Level 3
Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 7 38402557
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Georgina Crosbie
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Address
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Mater Prostate Cancer Research Centre
Mater Adult Hospital
Level 10
Raymond Terrace
South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 7 38403484
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Fax
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Email
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gcrosbie @mmri.mater.org.au
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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