Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

NCT01052142 | Completed Phase 1 DMC

• 1 other identifier: Lipovaxin-MM-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Melanoma; Cancer vaccines

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Within 84 days after first dose

• Immunogenicity

  antigen specific immune responses will be monitored

  Within 42 days of first dose

Secondary Outcomes (1)

• Anti-cancer activity (RECIST criteria)

  Within 84 days of first dose

Study Arms (1)

Lipovaxin-MM

EXPERIMENTAL

Biological: Lipovaxin-MM

Interventions

Lipovaxin-MM 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

Lipovaxin-MM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lipotek Pty Ltd: lead
• Royal Adelaide Hospital: collaborator
• Trident Clinical Research Pty Ltd: collaborator

Study Sites (1)

Pain & Anaesthesia Research Clinic

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Brown, MBBS FRACP FRCPA

  Royal Adelaide Hospital Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2010
• First Posted: January 20, 2010
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 11, 2012

Record last verified: 2012-04

Locations

AU (1)