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

Inclusion Criteria1

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 Criteria13

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.

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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.