Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052142
• Other study ID #: Lipovaxin-MM-001
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2010
• Last updated: April 10, 2012
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Lipotek Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
Australia	Pain & Anaesthesia Research Clinic	Adelaide	South Australia

Sponsors (3)

Lead Sponsor	Collaborator
Lipotek Pty Ltd	Royal Adelaide Hospital, Trident Clinical Research Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		Within 84 days after first dose	No
Primary	Immunogenicity	antigen specific immune responses will be monitored	Within 42 days of first dose	No
Secondary	Anti-cancer activity (RECIST criteria)	assessed every 6 weeks of study	Within 84 days of first dose	No