None listed
Conditions
Interventions
VMCL vaccine for 2 years
Sponsors
NHMRC Clinical Trials Centre in collaboration with the Sydney Melanoma Unit
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed