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
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Locations near you
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Full eligibility criteria for NCT01052142
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients with incurable stage IV malignant melanoma for which no standard or curative therapy exist OR patients 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 ≥12 weeks.
Female subjects must be of non-child-bearing potential or using appropriate contraception.
Positive test for cell mediated immunity. Key
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 IL-2 or interferon-based therapy) for melanoma.
Inadequate bone marrow reserve.
Serum bilirubin ≥1.2 times the upper limit of normal.
In 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 ≥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.
Immunosuppressive therapy including corticosteroids within 4 weeks of screening.
Pregnant or breast-feeding females.
All locations for NCT01052142
Pain & Anaesthesia Research Clinic
Adelaide, South Australia, Australia, 5000
View full eligibility
Tris trial is registered with FDA with number: NCT01052142. The sponsor of the trial is Lipotek Pty Ltd and it is looking for 12 volunteers for the current phase.
Official trial title: A Phase I Open-label Study of the Safety and Immunogenicity of Escalating Doses of Lipovaxin-MM, a Novel Melanoma Immunotherapeutic, in Patients With Metastatic Melanoma
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