Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000589684
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
5/10/2005
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prostate Cancer: An internal, solid-malignancy model for vaccine therapy
Scientific title
Phase II/III trial of immunotherapy based on cultured autologous dendritic cells presenting synthetic autologous Prostate Specific Membrane Antigen (PSMA) peptides with processed Keyhole Limpet Haemocyanin (KLH) as helper antigen for hormone refractory prostatic cancer to assess safety and effect on disease progression.
Secondary ID [1] 185 0
Queensland Institute of Medical Research (QIMR): QIMR P128
Universal Trial Number (UTN)
Trial acronym
NUQM00J1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone refractory prostate cancer 716 0
Condition category
Condition code
Cancer 793 793 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-blinded, 3 groups (randomised) examining two injection routes (intradermal and intravenous), of cultured autologous dendritic cells pulsed with soluble antigens. 6 injections with 4 weeks interval over 20 weeks.
Intervention code [1] 478 0
Treatment: Other
Comparator / control treatment
Control (saline)
Control group
Placebo

Outcomes
Primary outcome [1] 1012 0
Safety
Timepoint [1] 1012 0
Measured at 20 weeks
Primary outcome [2] 1013 0
Efficacy
Timepoint [2] 1013 0
Measured at 20 weeks
Secondary outcome [1] 1903 0
Changes in a variety of in vitro and in vivo immunological parameters correlated with clinical findings.
Timepoint [1] 1903 0
Assessed at 20 weeks.

Eligibility
Key inclusion criteria
Prostatic Cancer confirmed by biopsy, hormone refractory disease, HLA-A2+.
Minimum age
Not stated
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Bone metastasis, ECOG status>1, PSA <4ng/ml, Abnormal haematologic parameters, Abnormal liver and renal function paramenters, history of autoimmune disease or immunosuppressive therapy, previous radiotherapy, protatectomy, or lymphadectomy, positive serology for HIV, Hep B or Hep C, Significant non-malignant disease, Psychiatric, addictive or any conditions which compromise ability to participate in this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Single blind, fixed allocation, sequential, centrally assigned randomisation, independently supervised by QA administration using a list concealed from clinical investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No restriction method; sequence computer generated using the RANDOM module in the MS_DOS version of COMPUTER PROGRAMS FOR EPIDEMIOLOGISTS (PEPI) by J.H. Abramson and Paul M. Gahlinger.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/12/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 878 0
Charities/Societies/Foundations
Name [1] 878 0
Queensland Cancer Fund
Country [1] 878 0
Australia
Funding source category [2] 879 0
Charities/Societies/Foundations
Name [2] 879 0
Urological Society of Australia
Country [2] 879 0
Australia
Funding source category [3] 880 0
Charities/Societies/Foundations
Name [3] 880 0
philanthropic sources
Country [3] 880 0
Australia
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research (QIMR)
Address
300 Herston Rd, Herston 4006
Country
Australia
Secondary sponsor category [1] 744 0
None
Name [1] 744 0
Not applicable
Address [1] 744 0
Country [1] 744 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2166 0
Queensland Institute of Medical Research
Ethics committee address [1] 2166 0
Ethics committee country [1] 2166 0
Australia
Date submitted for ethics approval [1] 2166 0
Approval date [1] 2166 0
08/12/2000
Ethics approval number [1] 2166 0
EC 00278
Ethics committee name [2] 2167 0
Royal Brisbane and Womens' Hospital
Ethics committee address [2] 2167 0
Ethics committee country [2] 2167 0
Australia
Date submitted for ethics approval [2] 2167 0
Approval date [2] 2167 0
24/05/2000
Ethics approval number [2] 2167 0
EC00172

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

Contacts
Principal investigator
Name 35417 0
Address 35417 0
Country 35417 0
Phone 35417 0
Fax 35417 0
Email 35417 0
Contact person for public queries
Name 9667 0
Ms Betty Scells
Address 9667 0
University of Queensland
Clinical Sciences Building
Royal Brisbane and Womens' Hospital
Herston QLD 4006
Country 9667 0
Australia
Phone 9667 0
+61 7 33655233
Fax 9667 0
+61 7 33655559
Email 9667 0
b.scells@mailbox.uq.edu.au
Contact person for scientific queries
Name 595 0
Dr Chris Schmidt
Address 595 0
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4006
Country 595 0
Australia
Phone 595 0
+61 7 33620313
Fax 595 0
+61 7 38453510
Email 595 0
Chris.Schmidt@qimr.edu.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.