Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000702617
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
1/11/2005
Date last updated
28/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
VMCL
Scientific title
PHASE III RANDOMISED CONTROL STUDY OF THE EFFICACY OF VACCINIA MELANOMA CELL LYSATES IN TREATMENT OF PATIENTS WITH HIGH RISK PRIMARY AND STAGE II MELANOMA
Secondary ID [1] 213 0
National Clinical Trials Registry: NCTR32
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 851 0
Condition category
Condition code
Cancer 918 918 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VMCL vaccine for 2 years
Intervention code [1] 618 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1199 0
Disease free interval
Timepoint [1] 1199 0
Primary outcome [2] 1200 0
Disease free survival
Timepoint [2] 1200 0
Secondary outcome [1] 2191 0
Nil
Timepoint [1] 2191 0

Eligibility
Key inclusion criteria
Patients must have histologically confirmed malignant melanoma involving regional lymph nodes metastases or high risk primary melanoma. "High Risk" and regional lymph node metastases are classified as follows: * "High risk" stage I disease (group 1) is defined as (a) Breslow thickness of 4.0mm or greater, (b) Clark's level 5 of < 4.00mm that are histologically or clinically node negative. (Note: In patients with a depth of invasion 4.0mm, lymph node dissection is optional unless nodes are clinically involved). * Synchronous lymph node metastases, (groups 2 and 3) i.e. metastases detected within two months of removal of primary melanoma. Within this category are patients with (a) clinically positive lymph node metastases and (b) clinically negative but histologically positive lymph node metastases (detected because of elective lymph node dissection). * Delayed lymph node metastases, (groups 4 and 5) i.e. detection of clinically evident lymph node metastases two months or more after removal of primary melanoma. This category also includes occult melanoma with lymph node metastases confined to one or two adjacent lymph node fields. 2. The patient must be free of known or suspected metastases by physical examination and appropriate investigations such as liver function tests, haematology and chest x-rays. CAT scans of chest, abdomen and brain along with radioisotope scans of bone are to be performed if (a) lymph node metastases are detected > 2 years after removal of primary, OR (b) primary melanoma was > 3.9mm in thickness or > 1.4mm and ulcerated, OR (c) 3 ore more lymph nodes are involved. 3. Patients must be at least 14 years of age and less than 72. 4. The primary tumour must be surgically excised with an adequate margin of at least 2.00cm (except for primary tumours on the face where a 1.00cm margin is sufficient). Regional lymph node dissections must have intended clearance of the appropriate field (for suggested technique see Reference 5). Incomplete lymph node dissections are not acceptable. 5. Patients must be randomised and ready to commence vaccine injections within 8 weeks of 'definitive surgical treatment'. That is, from the time of the primary excision in the "high risk" lymph node negative group (group 1) and from the time of removal of lymph node metastases in the synchronous and delayed groups (groups 2,3,4 and 5). 6. ECOG performance status must be 0 or 1 (see Appendix C). 7. Pathological examination must include measurement of maximum depth of invasion (mm) of the primary cutaneous melanoma(s), the number of lymph nodes involved and whether there was extracapsular extension. 8. The patient must give written informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No past or concomitant malignancy except for basal or squamous cell cancer of the skin or cone biopsied carcinoma in situ of the uterine cervix. 2. No previous cytotoxic chemotherapy, immunotherapy or radiation therapy. No concomitant corticosteroid therapy or radiotherapy. (Note: Previously vaccinated patients are eligible). 3. Patients with eczema or who are immunosuppressed for any reason. 4. Patients with macroscopic or microscopic extra nodal invasion into surrounding soft tissues are not eligible. 5. No pregnancy. 6. Patients who are geographically unsuitable for therapy or follow-up are ineligible.

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)
Centralised randomisation database
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/12/1987
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1013 0
Other
Name [1] 1013 0
Country [1] 1013 0
Primary sponsor type
Government body
Name
NHMRC Clinical Trials Centre in collaboration with the Sydney Melanoma Unit
Address
Country
Australia
Secondary sponsor category [1] 875 0
Government body
Name [1] 875 0
Sydney Melanoma Unit
Address [1] 875 0
Country [1] 875 0
Australia
Secondary sponsor category [2] 876 0
University
Name [2] 876 0
NHMRC CTC
Address [2] 876 0
Country [2] 876 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36278 0
Address 36278 0
Country 36278 0
Phone 36278 0
Fax 36278 0
Email 36278 0
Contact person for public queries
Name 9807 0
Burcu Cakir
Address 9807 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9807 0
Australia
Phone 9807 0
+61 2 95625334
Fax 9807 0
+61 2 95625094
Email 9807 0
bcakir@ctc.usyd.edu.au
Contact person for scientific queries
Name 735 0
Peter Hersey
Address 735 0
Locked Bag 77
Camperdown NSW 1450
Country 735 0
Australia
Phone 735 0
+61 2 95625334
Fax 735 0
Email 735 0
Peter.Hersey@newcastle.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.