Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000424606
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dendritic cell vaccination trial for hormone refractory prostate cancer with autologous tumour as the antigen
Scientific title
Dendritic cell vaccination trial for hormone refractory prostate cancer with autologous tumour as the antigen to assess safety and effect on disease progression.
Secondary ID [1] 170 0
Queensland Institute of Medical Research (QIMR): QIMR P647
Universal Trial Number (UTN)
Trial acronym
NRQ03J1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone refractory prostate cancer 533 0
Condition category
Condition code
Cancer 613 613 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cultured autologous dendritic cells (DC) processed to present autologous prostate cancer antigens for treatment of hormone refractory prostate cancer. Vaccines are administered at 2 weekly intervals for 10 weeks and then 6-weekly for up to one year.
Intervention code [1] 482 0
Treatment: Other
Comparator / control treatment
None, phase I, single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 716 0
Safety assessed at each vaccination
Timepoint [1] 716 0
Every two weeks for 10 weeks and then every 6 weeks for up to 1 year
Secondary outcome [1] 1478 0
PSA levels tested at each vaccination
Timepoint [1] 1478 0
Every two weeks for 10 weeks and then every 6 weeks for up to 1 year.
Secondary outcome [2] 1479 0
Tumour stasis/regression assessed by radiography performed either.
Timepoint [2] 1479 0
At final assessment or as clinically indicated based on PSA levels.

Eligibility
Key inclusion criteria
Histologically proven prostatic Cancer, Maintenance hormone monotherapy, Serum PSA titres rising on 2 consecutive analyses, Minimum 5g of tumour-containing tissue.
Minimum age
Not stated
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key 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
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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 671 0
Charities/Societies/Foundations
Name [1] 671 0
Atlantic Philanthropies
Country [1] 671 0
Bermuda
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research (QIMR)
Address
300 Herston Rd, Herston
Country
Australia
Secondary sponsor category [1] 559 0
None
Name [1] 559 0
Not applicable
Address [1] 559 0
Country [1] 559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1853 0
Queensland Institute of Medical Research
Ethics committee address [1] 1853 0
Ethics committee country [1] 1853 0
Australia
Date submitted for ethics approval [1] 1853 0
Approval date [1] 1853 0
06/06/2003
Ethics approval number [1] 1853 0
EC00278
Ethics committee name [2] 1854 0
Royal Brisbane and Womens' Hospital
Ethics committee address [2] 1854 0
Ethics committee country [2] 1854 0
Australia
Date submitted for ethics approval [2] 1854 0
Approval date [2] 1854 0
26/05/2003
Ethics approval number [2] 1854 0
EC00172

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35872 0
Address 35872 0
Country 35872 0
Phone 35872 0
Fax 35872 0
Email 35872 0
Contact person for public queries
Name 9671 0
Ms Betty Scells
Address 9671 0
University of Queensland
Clinical Sciences Building
Royal Brisbane and Womens' Hospital
Herston QLD 4006
Country 9671 0
Australia
Phone 9671 0
+61 7 33655233
Fax 9671 0
+61 7 33655559
Email 9671 0
[email protected]
Contact person for scientific queries
Name 599 0
Dr Chris Schmidt
Address 599 0
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4006
Country 599 0
Australia
Phone 599 0
+61 7 33620313
Fax 599 0
+61 7 38453510
Email 599 0
[email protected]

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.