Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01052142
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : April 11, 2012
Royal Adelaide Hospital
Trident Clinical Research Pty Ltd
Information provided by (Responsible Party):
Lipotek Pty Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Lipovaxin-MM Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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

Primary Outcome Measures :
  1. Adverse events [ Time Frame: Within 84 days after first dose ]
  2. Immunogenicity [ Time Frame: Within 42 days of first dose ]
    antigen specific immune responses will be monitored

Secondary Outcome Measures :
  1. Anti-cancer activity (RECIST criteria) [ Time Frame: Within 84 days of first dose ]
    assessed every 6 weeks of study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01052142

Australia, South Australia
Pain & Anaesthesia Research Clinic
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Lipotek Pty Ltd
Royal Adelaide Hospital
Trident Clinical Research Pty Ltd
Principal Investigator: Michael Brown, MBBS FRACP FRCPA Royal Adelaide Hospital Cancer Centre

Responsible Party: Lipotek Pty Ltd Identifier: NCT01052142     History of Changes
Other Study ID Numbers: Lipovaxin-MM-001
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012

Keywords provided by Lipotek Pty Ltd:
Cancer vaccines

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas