None listed
Conditions
Brief summary
The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.
Interventions
Lipovaxin-MM 1mL, 3mL and 10mL doses, four administrations by slow intravenous injection at intervals of 1 week. Study is of sequential dose escalation. Total on study time is 84 days. All patients receive the same treatment; there is no comparator/control group.
Sponsors
Lipotek Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with incurable stage 4 (IV) malignant melanoma for which no standard or curative therapy exists OR patients with locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option . Must be able and willing to provide written informed consent. Eastern Cooperative Oncology Group Performance Status of 0 or 1. Life expectancy of at least 12 weeks. Female subjects must be of non-child-bearing potential or using appropriate contraception. Positive test for cell mediated immunity.
Exclusion criteria
Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks. Previous immunotherapy (except interleukin-2 (IL-2)- or interferon-based therapy) for melanoma. Inadequate bone marrow reserve. Serum bilirubin at least 1.2 times the upper limit of normal. In the absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal. If metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable. Inadequate renal function. Evidence of severe or uncontrolled systemic diseases. Unresolved toxicity at least Common Toxicity Criteria (CTC) Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor. Participation in a trial of an investigational agent within the prior 30 days. Human immunodeficiency virus (HIV) infection. Immunosuppressive therapy including corticosteroids within 4 weeks of screening. Pregnant or breast-feeding females.
Outcome results
None listed