Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000149066
Ethics application status
Approved
Date submitted
19/01/2010
Date registered
12/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

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] 1371 0
NCT01052142
Universal Trial Number (UTN)
Trial acronym
Lipovaxin-MM-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 252369 0
Condition category
Condition code
Cancer 256550 256550 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lipovaxin-MM 1mL, 3mL and 10mL doses, four administrations by slow intravenous injection at intervals of 1 week. Study is of sequential dose escalation. Total on study time is 84 days. All patients receive the same treatment; there is no comparator/control group.
Intervention code [1] 255671 0
Treatment: Other
Intervention code [2] 255963 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253433 0
Safety. Assessments will be based on medical review of adverse event reports and results of vital sign measurements, electrocardiograms and traces, physical examinations and clinical laboratory tests, including urinalysis, biochemistry and haematology. This is a first in human study so the adverse event profile is unknown.
Timepoint [1] 253433 0
Assessments performed routinely throughout the study.
Primary outcome [2] 253434 0
Immunogenicity. Humoral immune responses will be measured in serum using enzyme-linked immunosorbent assay. Cellular immune responses will be measured in peripheral blood mononuclear cells using intracellular cytokine staining, cytometric bead array assay and flow cytometry.
Timepoint [2] 253434 0
assessed at days 0, 21 and 42 of the study.
Secondary outcome [1] 262564 0
Tumour response. Determined using Response Evaluation Criteria in Solid Tumours (RECIST).
Timepoint [1] 262564 0
Assessments made every 6 weeks for 12 weeks

Eligibility
Key inclusion criteria
Patients with incurable stage 4 (IV) malignant melanoma for which no standard or curative therapy exists OR patients with 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 at least 12 weeks. Female subjects must be of non-child-bearing potential or using appropriate contraception. Positive test for cell mediated immunity.
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 interleukin-2 (IL-2)- or interferon-based therapy) for melanoma.
Inadequate bone marrow reserve.
Serum bilirubin at least 1.2 times the upper limit of normal.
In the 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 at least Common Toxicity Criteria (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.
Human immunodeficiency virus (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
Non-randomised trial
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
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 256150 0
Commercial sector/Industry
Name [1] 256150 0
Lipotek Pty Ltd
Country [1] 256150 0
Australia
Funding source category [2] 256154 0
Government body
Name [2] 256154 0
Climate Ready Program
Country [2] 256154 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lipotek Pty Ltd
Address
Building 46 - RN Robertson
Biology Place - Australian National University, ACT 0200
Country
Australia
Secondary sponsor category [1] 251501 0
None
Name [1] 251501 0
Address [1] 251501 0
Country [1] 251501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258252 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 258252 0
Ethics committee country [1] 258252 0
Australia
Date submitted for ethics approval [1] 258252 0
Approval date [1] 258252 0
29/06/2009
Ethics approval number [1] 258252 0
081124

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30598 0
Address 30598 0
Country 30598 0
Phone 30598 0
Fax 30598 0
Email 30598 0
Contact person for public queries
Name 13845 0
Melanie Gentgall
Address 13845 0
Clinical Research Manager
Pain and Anaesthesia Research Clinic - PARC
Ward S4A, Level 4, RAH
North Terrace
Adelaide SA 5000
Country 13845 0
Australia
Phone 13845 0
+61 8 8222 2712
Fax 13845 0
Email 13845 0
[email protected]
Contact person for scientific queries
Name 4773 0
Professor Michael Brown
Address 4773 0
Director of Cancer Clinical Trials
RAH Cancer Centre
Royal Adelaide Hospital
MDP 11, Level 4, East Wing
North Terrace
Adelaide SA 5000
Country 4773 0
Australia
Phone 4773 0
+61 8 8222 4157
Fax 4773 0
+61 8 8222 4358
Email 4773 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.