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Trial registered on ANZCTR


Registration number
ACTRN12605000423617
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
Phase I trial of the safety and the effect on immune parameters of an immunotherapy for glioma based on cultured autologous dendritic cells presenting autologous tumour cell antigens derived from irradiated glioma cells
Scientific title
Phase I trial of the safety and the effect on immune parameters of an immunotherapy for glioma based on cultured autologous dendritic cells presenting autologous tumour cell antigens derived from irradiated glioma cells
Secondary ID [1] 169 0
Queensland Institute of Medical Research (QIMR): QIMR P570
Universal Trial Number (UTN)
Trial acronym
RMQ0331
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 532 0
Condition category
Condition code
Cancer 612 612 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous dendritic cell vaccine using autologous irradiated cells as antigen source administered at 2 weekly intervals for the first 6 injections, then 6 weekly thereafter, for 1 year or until disease progression.
Intervention code [1] 481 0
Treatment: Other
Comparator / control treatment
No comparator (phase 1, single arm study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 715 0
Safety
Timepoint [1] 715 0
After each vaccine (fortnightly for 6 injections, then 6 weekly for 1 year.) Evaluations will also be performed within 6 weeks of the final vaccination and whenever clinically indicatedor until disease progression). Final analysis will occur by 14 months after the last patient entered into the study had their first vaccination.
Secondary outcome [1] 1477 0
Clinical efficacy based on the time interval between the first vaccination and disease progression.
Timepoint [1] 1477 0
Disease progression is assessed at vaccination (fortnightly for 6 injections, then 6 weekly for 1 year, within 6 weeks of the final vaccination and whenever clinically indicated. Final analysis will occur by 14 months after the last patient entered into the study had their first vaccination.

Eligibility
Key inclusion criteria
Confirmed Malignant Glioma, Macroscopic tumour resection, normal haematolological parameters, acceptable liver and renal function parameters.
Minimum age
1 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Extensive intracranial disease precluding total or subtotal resection, ECOG status >2, History of autoimmune disease or immunosuppressive therapy, Prior use of immunotherapeutic agent, Positive serology for HIV, Hep B or Hep C, Significant non-malignant disease, Pregnancy, Other malignancy, Patients in whom only biopsy or partial resection was possible.

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 669 0
Charities/Societies/Foundations
Name [1] 669 0
The Sylvia and Charles Viertel Charitable Foundation
Address [1] 669 0
ANZ Trustees LTD, 100 Queen St Melbourne 3000
Country [1] 669 0
Australia
Funding source category [2] 670 0
Charities/Societies/Foundations
Name [2] 670 0
Royal Brisbane and Womens' Hospital Research Foundation
Address [2] 670 0
Block 20, Butterfield St, Herston 4006
Country [2] 670 0
Australia
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research (QIMR)
Address
300 Herston Rd, Herston Brisbane 4006
Country
Australia
Secondary sponsor category [1] 558 0
None
Name [1] 558 0
Not applicable
Address [1] 558 0
Country [1] 558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1850 0
QIMR
Ethics committee address [1] 1850 0
Herston, QLD 4006
Ethics committee country [1] 1850 0
Australia
Date submitted for ethics approval [1] 1850 0
Approval date [1] 1850 0
11/07/2003
Ethics approval number [1] 1850 0
EC00278
Ethics committee name [2] 1851 0
Royal Brisbane and Womens' Hospital
Ethics committee address [2] 1851 0
Herston, QLD 4029
Ethics committee country [2] 1851 0
Australia
Date submitted for ethics approval [2] 1851 0
Approval date [2] 1851 0
16/06/2003
Ethics approval number [2] 1851 0
EC00172
Ethics committee name [3] 1852 0
Mater Misericordiae Hospital
Ethics committee address [3] 1852 0
South Brisbane, QLD 4101
Ethics committee country [3] 1852 0
Australia
Date submitted for ethics approval [3] 1852 0
Approval date [3] 1852 0
12/08/2003
Ethics approval number [3] 1852 0
EC00332

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

Contacts
Principal investigator
Name 35826 0
Address 35826 0
Country 35826 0
Phone 35826 0
Fax 35826 0
Email 35826 0
Contact person for public queries
Name 9670 0
Dr David Walker
Address 9670 0
Department of Neurosurgery
Royal Brisbane and Womens' Hospital
Brisbane QLD 4029
Country 9670 0
Australia
Phone 9670 0
+61 7 36367470
Fax 9670 0
+61 7 36362632
Email 9670 0
David_Walker@health.qld.gov.au
Contact person for scientific queries
Name 598 0
Dr Chris Schmidt
Address 598 0
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4006
Country 598 0
Australia
Phone 598 0
+61 7 33620313
Fax 598 0
+61 7 38453510
Email 598 0
Chris.Schmidt@qimr.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary