Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000590662
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
5/10/2005
Date last updated
10/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase III trial of an immunotherapy for Stage III (AJCC) melanoma based on cultured autologous dendritic cells presenting autologous tumour cell antigens
Scientific title
Phase III trial of an immunotherapy for Stage III (AJCC) melanoma based on cultured autologous dendritic cells presenting autologous tumour cell antigens to test the effect on distant disease-free survival at 2 years, time to distant, or untreatable local recurrence and safety.
Secondary ID [1] 186 0
Queensland Institute of Medical Research (QIMR): QIMR P742
Universal Trial Number (UTN)
Trial acronym
MRPQ0161(A)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage III B/C (AJCC) Melanoma 717 0
Condition category
Condition code
Cancer 794 794 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: autologous dendritic cell vaccine using autologous irradiated tumor cells as antigen source;
Duration of intervention: two years or until disease recurrence.
Intervention code [1] 483 0
Treatment: Other
Comparator / control treatment

Control: autologous peripheral mononuclear blood cells
Control group
Placebo

Outcomes
Primary outcome [1] 1014 0
Distant disease-free survival at 2 years
Timepoint [1] 1014 0
Safety assessments as clinically indicated and at each vaccination visit (fortnightly for a max of 8 weeks, then every 3 months) for first two years, then 6 monthly for 12 months.
Primary outcome [2] 1015 0
Time to distant, or untreatable local recurrence
Timepoint [2] 1015 0
Safety assessments as clinically indicated and at each vaccination visit (fortnightly for a max of 8 weeks, then every 3 months) for first two years, then 6 monthly for 12 months.
Secondary outcome [1] 1904 0
Overall survival
Timepoint [1] 1904 0
As information becomes available and at the end of the follow up period
Secondary outcome [2] 1905 0
Changes in in vivo and in vitro immunological responsiveness to autologous melanoma at each vaccination.
Timepoint [2] 1905 0
fortnightly for up to 8 weeks, then 3 monthly for up to 2 years

Eligibility
Key inclusion criteria
Histologically confirmed melanoma of Stage III; ECOG status 0; Normal Haematolology; Acceptable Renal and Liver function parameters; Negative serology for HIV, Hep B and C;Informed written consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Autoimmune disease or immunosuppressant use, Prior chemotherapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, post-operative complications which would preclude experimental vaccine therapy, Unsuccessful vaccine preparation, Clinically significant active infection, Uncontrolled systemic disease or medical problems, History of other malignancies (except for adequately treated and controlled non-melanomatic skin cancer or in situ cervical cancer), Pregnancy.

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)
Double blind, fixed allocation, sequential, centrally assigned randomisation, performed by QA administration using a list concealed from clinical investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block design, fixed allocation randomization based on stratification variables. Sequence generated using SAS.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
22/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 881 0
Charities/Societies/Foundations
Name [1] 881 0
Atlantic Philanthropies
Country [1] 881 0
United Kingdom
Funding source category [2] 882 0
Charities/Societies/Foundations
Name [2] 882 0
Queensland Cancer Fund
Country [2] 882 0
Australia
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research (QIMR)
Address
300 Herston Rd, Herston, Queensland 4006
Country
Australia
Secondary sponsor category [1] 745 0
None
Name [1] 745 0
Not applicable
Address [1] 745 0
Country [1] 745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2168 0
QIMR
Ethics committee address [1] 2168 0
Ethics committee country [1] 2168 0
Australia
Date submitted for ethics approval [1] 2168 0
Approval date [1] 2168 0
06/02/2004
Ethics approval number [1] 2168 0
EC00278
Ethics committee name [2] 2169 0
Princess Alexandra Hospital
Ethics committee address [2] 2169 0
Ethics committee country [2] 2169 0
Australia
Date submitted for ethics approval [2] 2169 0
Approval date [2] 2169 0
20/01/2004
Ethics approval number [2] 2169 0
EC00332
Ethics committee name [3] 2170 0
Mater Misericordiae Hospital
Ethics committee address [3] 2170 0
Ethics committee country [3] 2170 0
Australia
Date submitted for ethics approval [3] 2170 0
Approval date [3] 2170 0
Ethics approval number [3] 2170 0

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

Contacts
Principal investigator
Name 36189 0
Address 36189 0
Country 36189 0
Phone 36189 0
Fax 36189 0
Email 36189 0
Contact person for public queries
Name 9672 0
Ms Maree Johnson
Address 9672 0
Department of Surgery
Mater Adult Hospital
Brisbane QLD 4012
Country 9672 0
Australia
Phone 9672 0
+61 7 38401696
Fax 9672 0
+61 7 38401696
Email 9672 0
[email protected]
Contact person for scientific queries
Name 600 0
Dr Chris Schmidt
Address 600 0
Queensland Institute of Medical Research 300 Herston Road
Herston QLD 4006
Country 600 0
Australia
Phone 600 0
+61 7 33620313
Fax 600 0
+61 7 38453510
Email 600 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.