Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 112 0
Mater Medical Research Institute (MMRI): CT2-PC-BDCA-1BDC-01
Universal Trial Number (UTN)
Trial acronym
MMRI#CT2-PC-BDCA-1BDC-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic hormone refractory prostate cancer 218 0
Condition category
Condition code
Cancer 245 245 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 134 0
Treatment: Other
Comparator / control treatment
No compartor/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291 0
This study has been designed prinicpally to assess the safety of BDCA-1BDC-01 in patients with metastatic hormone refractory prostate cancer
Timepoint [1] 291 0
End of Study 5.5 months
Secondary outcome [1] 648 0
To evaluate the preliminary efficacy of the vaccine in the induction of an immune response against metastatic hormone refractory prostate cancer after 3 vaccinates.
Timepoint [1] 648 0
End of Study 5.5 months
Secondary outcome [2] 649 0
The evaluation of the disease response to the 3 vaccines in patients with metastatic hormone refractory prostate cancer.
Timepoint [2] 649 0
End of Study 5.5 months

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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304 0
Other
Name [1] 304 0
Mater Medical Research Institute
Country [1] 304 0
Australia
Funding source category [2] 4111 0
Charities/Societies/Foundations
Name [2] 4111 0
Mater Foundation
Country [2] 4111 0
Australia
Primary sponsor type
Other
Name
Mater Medical Research Institute
Address
Level 3 Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 236 0
None
Name [1] 236 0
Nil
Address [1] 236 0
Country [1] 236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1174 0
Mater Health Services
Ethics committee address [1] 1174 0
Ethics committee country [1] 1174 0
Australia
Date submitted for ethics approval [1] 1174 0
Approval date [1] 1174 0
Ethics approval number [1] 1174 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36371 0
Address 36371 0
Country 36371 0
Phone 36371 0
Fax 36371 0
Email 36371 0
Contact person for public queries
Name 9323 0
Professor Derek Hart
Address 9323 0
Level 3
Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Country 9323 0
Australia
Phone 9323 0
+61 7 38402557
Fax 9323 0
Email 9323 0
[email protected]
Contact person for scientific queries
Name 251 0
Georgina Crosbie
Address 251 0
Mater Prostate Cancer Research Centre
Mater Adult Hospital
Level 10
Raymond Terrace
South Brisbane QLD 4101
Country 251 0
Australia
Phone 251 0
+61 7 38403484
Fax 251 0
Email 251 0
gcrosbie @mmri.mater.org.au

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.