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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01052142




Registration number
NCT01052142
Ethics application status
Date submitted
18/01/2010
Date registered
20/01/2010
Date last updated
11/04/2012

Titles & IDs
Public title
Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma
Scientific 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
Secondary ID [1] 0 0
Lipovaxin-MM-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Lipovaxin-MM

Experimental: Lipovaxin-MM -


Other 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Within 84 days after first dose
Primary outcome [2] 0 0
Immunogenicity
Timepoint [2] 0 0
Within 42 days of first dose
Secondary outcome [1] 0 0
Anti-cancer activity (RECIST criteria)
Timepoint [1] 0 0
Within 84 days of first dose

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Pain & Anaesthesia Research Clinic - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lipotek Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Adelaide Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Trident Clinical Research Pty Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01052142
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Brown, MBBS FRACP FRCPA
Address 0 0
Royal Adelaide Hospital Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01052142