MelanomaPhase 1NCT01052142
Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma
A Phase 1 study testing Lipovaxin-MM in people with Melanoma, run by Lipotek Pty Ltd at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Lipovaxin-MM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2009to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Pain & Anaesthesia Research Clinic
Adelaide, South Australia, 5000
About this study
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
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
- Being tested
- Lipovaxin-MM
- Keywords
- Melanoma, Cancer vaccines
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipovaxin-MMBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Lipovaxin-MM | Experimental | Not described Receives: Biological: Lipovaxin-MM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Within 84 days after first dose
Immunogenicity
antigen specific immune responses will be monitored
Measured: Within 42 days of first dose
Secondary outcomes (1)
Anti-cancer activity (RECIST criteria)
assessed every 6 weeks of study
Measured: Within 84 days of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipotek Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Adelaide Hospital, Trident Clinical Research Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Michael Brown, MBBS FRACP FRCPA, Principal investigator, Royal Adelaide Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052142
- Sponsor's protocol ID
- Lipovaxin-MM-001
- Status last verified
- Apr 2012
- First submitted
- 18 Jan 2010
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01052142
- Acronym / sponsor ID
- Lipovaxin-MM-001
- Conditions
- Melanoma
- Keywords
- Melanoma, Cancer vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lipotek Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Royal Adelaide Hospital, Trident Clinical Research Pty Ltd
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipovaxin-MM | Experimental | Biological: Lipovaxin-MM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipovaxin-MMPatients 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 | Biological | Lipovaxin-MM |
Primary outcome
Adverse events
Time frame: Within 84 days after first dose
Immunogenicity
Time frame: Within 42 days of first dose
antigen specific immune responses will be monitored
1 secondary outcome
Anti-cancer activity (RECIST criteria)
Time frame: Within 84 days of first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Brown, MBBS FRACP FRCPA principal investigator
Royal Adelaide Hospital Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lipovaxin-MM in people with Melanoma, run by Lipotek Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Within 84 days after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.