Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* Biological: Lipovaxin-MM


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 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 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. HIV infection. Immunosuppressive therapy including corticosteroids within 4 weeks of screening. Pregnant or breast-feeding females.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipovaxin-MM<br> | Biological: Lipovaxin-MM<br>* Patients will receive three doses of Lipovaxin-MM by intravenous infusion at intervals of four weeks OR patients will receive 4 doses of Lipovaxin-MM by intravenous infusion at weekly intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Within 84 days after first dose | 
| Immunogenicity | antigen specific immune responses will be monitored | Within 42 days of first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-cancer activity (RECIST criteria) | assessed every 6 weeks of study | Within 84 days of first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Cancer vaccines