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
ACTRN12605000425695
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
29/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
VMCL Melanoma Vaccine Treatment Phase II Study for Therapy of Patients with Advanced Stage IV Melanoma
Scientific title
VMCL Melanoma Vaccine Treatment Phase II Study for Therapy of Patients with Advanced Stage IV Melanoma
Universal Trial Number (UTN)
Trial acronym
VMCL Stage IV Melanoma Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Stage IV Melanoma 534 0
Condition category
Condition code
Cancer 614 614 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment of patients with Advanced Stage IV Melanoma using Vaccinia Melanoma Cell Lysate (VMCL). VMCL is currently an unregistered experimental agent that has been previously tested for treatment of stage III melanoma patients in a large Australian trial. This showed the agent to have a high degree of safety with very few adverse events. The scheduled treatment period will be 18 months, however, the treatment may be continued in individuals who show a significant clinical response.
Intervention code [1] 515 0
None
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 717 0
Efficacy, measured by performance status (ECOG score).
Timepoint [1] 717 0
Evaluated at regular time-points according to the schedule of clinical visits initially 2-weekly, then monthly, then 3-monthly.
Primary outcome [2] 718 0
Overall survival, measured by performance status (ECOG score).
Timepoint [2] 718 0
Evaluated at regular time-points according to the schedule of clinical visits initially 2-weekly, then monthly, then 3-monthly.
Secondary outcome [1] 1480 0
A range of immunological measures that will be correlated with clinical outcome. The aim is to determine any associations between clinical responses and immunological parameters, in order to better predict who might respond to VMCL therapy.
Timepoint [1] 1480 0
These will be evaluated at regular time-points according to the schedule of clinical visits and blood tests initially 2-weekly, then monthly, then 3-monthly. A further aim is to design better therapy.

Eligibility
Key inclusion criteria
Stage IV advanced melanoma with soft tissue/organ metastases; Absence of Brain Metastases; Absence of ocular melanoma associated retinopathy /iritis; Willingness to attend all scheduled clinical visits, tests and blood sampling.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Solitary bone metastases; Large volume metastatic disease; Poor performance status; Pregnancy; Other malignancy.

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 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 672 0
Other
Name [1] 672 0
Address [1] 672 0
Country [1] 672 0
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital/University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 560 0
Individual
Name [1] 560 0
Assoc Professor BJ Coventry
Address [1] 560 0
Country [1] 560 0
Secondary sponsor category [2] 561 0
Individual
Name [2] 561 0
Professor P Hersey
Address [2] 561 0
Country [2] 561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1855 0
Royal Adelaide Hospital/University of Adelaide
Ethics committee address [1] 1855 0
Ethics committee country [1] 1855 0
Australia
Date submitted for ethics approval [1] 1855 0
Approval date [1] 1855 0
Ethics approval number [1] 1855 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Coventry BJ, Hersey P, Halligan A-M, Michele A. Immuno-Chemotherapy Using Repeated Vaccine Treatment Can Produce Successful Clinical Responses in Advanced Metastatic Melanoma. Journal of Cancer Therapy, 2010, 1: 205-213.
Public notes

Contacts
Principal investigator
Name 36096 0
Address 36096 0
Country 36096 0
Phone 36096 0
Fax 36096 0
Email 36096 0
Contact person for public queries
Name 9704 0
Ms Nicki Bator
Address 9704 0
Adelaide Melanoma Unit
Department of Surgery
University of Adelaide
Royal Adelaide Hospital
L5 Eleanor Harrod Building (EHB)
North Terrace
Adelaide SA 5000
Country 9704 0
Australia
Phone 9704 0
+61 8 82224154
Fax 9704 0
+61 8 82225896
Email 9704 0
nbator
Contact person for scientific queries
Name 632 0
Assoc Professor Brendan Coventry
Address 632 0
Adelaide Melanoma Unit
Department of Surgery
University of Adelaide
Royal Adelaide Hospital
L5 Eleanor Harrod Building (EHB)
North Terrace
Adelaide SA 5000
Country 632 0
Australia
Phone 632 0
+61 8 82224154
Fax 632 0
+61 8 82225896
Email 632 0
bcoventry@medicine.adelaide.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