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
  Purpose

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 Intervention Phase
Melanoma
Biological: Lipovaxin-MM
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lipotek Pty Ltd:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Anti-cancer activity (RECIST criteria) [ Time Frame: Within 84 days of first dose ] [ Designated as safety issue: No ]
    assessed every 6 weeks of study


Enrollment: 12
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052142

Locations
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
Investigators
Principal Investigator: Michael Brown, MBBS FRACP FRCPA Royal Adelaide Hospital Cancer Centre
  More Information

No publications provided

Responsible Party: Lipotek Pty Ltd
ClinicalTrials.gov Identifier: NCT01052142     History of Changes
Other Study ID Numbers: Lipovaxin-MM-001
Study First Received: January 18, 2010
Last Updated: April 10, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Lipotek Pty Ltd:
Melanoma
Cancer vaccines

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

ClinicalTrials.gov processed this record on April 21, 2014