CompletedPhase 1ACTRN12610000149066

Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

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

Sponsor

Lipotek Pty Ltd

Enrollment

24 participants

Start Date

Sep 7, 2009

Study Type

Interventional

Conditions

Malignant Melanoma

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests the safety of a vaccine delivered in tiny fat particles (liposomes) for patients with advanced melanoma (skin cancer) that cannot be cured with standard treatments. It is designed for adults aged 18 and older with stage 4 melanoma or melanoma that has come back in the nearby area and cannot be removed by surgery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.