Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

NCT ID: NCT01052142

Last Updated: 2012-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipovaxin-MM

Group Type: EXPERIMENTAL

Lipovaxin-MM

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Adelaide Hospital

OTHER

Sponsor Role: collaborator

Trident Clinical Research Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Lipotek Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Brown, MBBS FRACP FRCPA

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital Cancer Centre

Locations

Pain & Anaesthesia Research Clinic

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

Lipovaxin-MM-001

Identifier Type: -

Identifier Source: org_study_id