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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Biological: Lipovaxin-MM

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Pain & Anaesthesia Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lipovaxin-MM	Biological: Lipovaxin-MM; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lipotek Pty Ltd
• Collaborators: Royal Adelaide Hospital; Trident Clinical Research Pty Ltd
• Investigators: Principal Investigator: Michael Brown, MBBS FRACP FRCPA, Royal Adelaide Hospital Cancer Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 18, 2010
• First Submitted That Met QC Criteria: January 18, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): April 11, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Melanoma; Cancer vaccines
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: Lipovaxin-MM-001