None listed
Conditions
Brief summary
This study is evaluating the effect of timed vaccine and chemotherapy delivery in advanced melanoma patients. You may be eligible to join this study if you are a male or female aged 18 years or above who has been diagnosed with advanced melanoma (Stage IV or IIIB/IIIC) that cannot be treated with surgery. Participants in this trial will be randomly allocated to one of two groups. Participants in groups one and two will both receive the VCML vaccine. Group one will receive regular, pre-determined vaccinations whereas Group two will have their vaccination times determined by blood test results. If disease progression occurs, then participants in group one will receive oral chemotherapy treatment on pre-determined dates, whereas participants in group 2 will receive oral chemotherapy at times determined by the results of blood tests. The treatment in group 1 will not be timed in this way. All participants will be assessed on a regular basis for a period of up to 5 years in order to determine whether treatment response and overall survival differ between groups. This will enable us to determine whether the timing of vaccine or chemotherapy administration can improve treatment response.
Interventions
Arm 1 - Control Arm: 0.3 ml VMCL Vaccine Untimed, administered via intra-dermal injection. If progression occurs, then addition of oral chemotherapy (cyclophosphamide -100mg tablet) every 3 weeks, until disease regression/progression. Arm 1 therapies are administered on a regular, pre-determined basis per protocol schedule.
Arm 2 - Test Arm: 0.3 ml VMCL vaccine Timed, administered via intra-dermal injection. If progression occurs, then addition of timed oral chemotherapy (cyclophosphamide - 100m
Arm 1 - Control Arm: 0.3 ml VMCL Vaccine Untimed, administered via intra-dermal injection. If progression occurs, then addition of oral chemotherapy (cyclophosphamide -100mg tablet) every 3 weeks, until disease regression/progression. Arm 1 therapies are administered on a regular, pre-determined basis per protocol schedule. Arm 2 - Test Arm: 0.3 ml VMCL vaccine Timed, administered via intra-dermal injection. If progression occurs, then addition of timed oral chemotherapy (cyclophosphamide - 100mg tablet) as dictated by patients immune system cycle profile (approximately 3 weekly), until disease regression/progression. Arm 2 therapies are co-ordinated with the patient's own immune cycle, as determined by regular blood tests.
Sponsors
Australian Melanoma Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
18 - 80 years of age. ECOG 0-2. Evaluable metastases. Primary cutaneous melanoma. Advanced surgically non-resectable AJCC Stage IIIB/IIIC or IV. Able to give informed consent. Tumour volume < 20cm diameter or <70% of organ replacement.
Exclusion criteria
Presence of another primary invasive cancer (not BCC, SCC or resected in-situ malignancy) Untreated brain mets Extremely extensive disease Bone mets only High dose oral steroid therapy Pregnancy or lactation Severe atopia Severe cachexia Immunodeficiency HIV Hep B or C +ve
Outcome results
None listed