Phase III trial of an immunotherapy for Stage III (AJCC) melanoma based on cultured autologous dendritic cells presenting autologous tumour cell antigens
Phase 3
- Conditions
- Stage III B/C (AJCC) MelanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12605000590662
- Lead Sponsor
- Queensland Institute of Medical Research (QIMR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 200
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distant disease-free survival at 2 years[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.];Time to distant, or untreatable local recurrence[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 Measures
Name Time Method Overall survival[As information becomes available and at the end of the follow up period];Changes in in vivo and in vitro immunological responsiveness to autologous melanoma at each vaccination.[fortnightly for up to 8 weeks, then 3 monthly for up to 2 years]