Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

Phase 1

Completed

• Conditions: Melanoma
• Interventions: Biological: Lipovaxin-MM

• Registration Number: NCT01052142
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-18
• Study First Posted: 2010-01-20
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipovaxin-MM	Lipovaxin-MM	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Within 84 days after first dose
Immunogenicity	Within 42 days of first dose	antigen specific immune responses will be monitored

Secondary Outcome Measures

Name	Time	Method
Anti-cancer activity (RECIST criteria)	Within 84 days of first dose	assessed every 6 weeks of study

Trial Locations

Locations (1)

Pain & Anaesthesia Research Clinic; 🇦🇺 Adelaide, South Australia, Australia