Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

This study has been completed.
Sponsor:
Collaborators:
Royal Adelaide Hospital
Trident Clinical Research Pty Ltd
Information provided by (Responsible Party):
Lipotek Pty Ltd
ClinicalTrials.gov Identifier:
NCT01052142
First received: January 18, 2010
Last updated: April 10, 2012
Last verified: April 2012

January 18, 2010
April 10, 2012
September 2009
March 2012   (final data collection date for primary outcome measure)
  • Adverse events [ Time Frame: Within 84 days after first dose ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Within 42 days of first dose ] [ Designated as safety issue: No ]
    antigen specific immune responses will be monitored
  • Adverse events [ Time Frame: Within 112 days after first dose ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Within 112 days of first dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01052142 on ClinicalTrials.gov Archive Site
Anti-cancer activity (RECIST criteria) [ Time Frame: Within 84 days of first dose ] [ Designated as safety issue: No ]
assessed every 6 weeks of study
Anti-cancer activity (RECIST criteria) [ Time Frame: Within 112 days of first dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
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
Experimental: Lipovaxin-MM
Intervention: Biological: Lipovaxin-MM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01052142
Lipovaxin-MM-001
Yes
Lipotek Pty Ltd
Lipotek Pty Ltd
  • Royal Adelaide Hospital
  • Trident Clinical Research Pty Ltd
Principal Investigator: Michael Brown, MBBS FRACP FRCPA Royal Adelaide Hospital Cancer Centre
Lipotek Pty Ltd
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP