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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Molecular Profile of Melanoma Chemosensitivity and Resistance
Scientific title
A study to determine if collecting molecular information from the tumours of patients with disseminated melanoma can provide information about tumour chemosensitivity.
Universal Trial Number (UTN)
Trial acronym
Melanoma Chemosensitivity Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma 3389 0
Condition category
Condition code
Cancer 3538 3538 0 0
Malignant melanoma

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1.All patients in this study will receive the standard treatment for metastatic melanoma when its isolated to a limb.The standard treatment is an Isoloated Limb Infusion (ILI).An Isoloated Limb Infusion is where a limb is isolated by a tourniquet & anti-cancer drug are given via venous & arterial catheters. Prior to the ILI patients will have a small amount tumour taken. This is the only time tumour is taken.
Tumour material will be immediately debrided, cut into small pieces and snap-frozen in liquid nitrogen, then transported to the Westmead Institute for Cancer Research laboratories where RNA will be extracted as previously described (, batched, and shipped to NIH, Bethesda for preparation of fluorescently-labelled cDNA and microarray analysis. The purpose of this study is to establish a genome scale expression database for melanoma in vivo that does, and does not, respond to standard chemotherapy. This entirely new type of data will provide the basis for "mining" the genome for genes which are relevant to melanoma treatment.
Patients will be assessed the first week post-procedure, then at 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months and 24 months or up until patients progress. Each visit will have a plus or minus one week window. The assessments will consist of a physical assessment. At each visit the following observations will be undertaken as part of the observational study, tumour measurements, limb photography and blood sampling for Lactate Dehydroginase(LDH)
Intervention code [1] 2982 0
Not applicable
Comparator / control treatment
no control group
Control group

Primary outcome [1] 4303 0
By microarray analysis, to determine the profile of expressed molecules in metastatic melanoma in two groups of patients: a) those responding to standard Isolated Limb Infusion (ILI) with melphalan and fotemustine, and b) those who fail to respond.
Timepoint [1] 4303 0
Patients will be assessed the first week post-procedure, then at 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months and 24 months.
Secondary outcome [1] 7248 0
By microarray analysis, to determine the molecular profile of expressed molecules in the circulating T-lymphocytes.
Timepoint [1] 7248 0
Patients will be assessed the first week post-procedure, then at 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months and 24 months.
Secondary outcome [2] 7250 0
In selected patients, where repeat biopsy is possible post-therapy, to determine, by microarray analysis, the molecular signature of non-responding tumours after exposure to chemotherapy, in order to ascertain the presence of induced molecules relevant to chemoresistance.
Timepoint [2] 7250 0
Patients will be assessed the first week post-procedure, then at 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months and 24 months.

Key inclusion criteria
1.Histologically confirmed malignant melanoma with locoregional recurrence in a pattern deemed to be suitable for Isolated Limb Infusion (ILI).
2.Age: 17 years and over.
3.Patients may be untreated, surgically treated, or may have received prior radiation therapy, chemotherapy, immunotherapy or prior Isolated Limb Infusion(ILIs). Patients may have received prior immunotherapy with Vaccinia Melanoma Cell Lysate (VMCL) or Canvaxin (C-VAX) vaccines.
4.There must be one or more bidimensionally measurable masses evaluated using the metric system, taken within 1 week of the on-study date. Measurements may be made by photograph and/or palpation.
5.At least one metastatic site, in addition to measurable site(s), which is amenable to biopsy prior to therapy. Biopsy will be by surgical excision.
6.Life expectancy of 3 months or more and be able to undergo routine outpatient evaluations.
7.Clinically adequate haematological, bone marrow, kidney, cardiac and liver function.
8.Hemoglobin greater than 9.0 g/dL. white blood cell count greater than 2.0 x l09 cells/L, absolute neutrophil count greater than 1.0 x 109cells/L, platelet count greater than 90 x 109/L and a Partial Thromboplastin Time (PTT or APTT) within normal limits at time of prestudy evaluation.
9.Serum creatinine less than or equal to 180 umol/L.
10.Serum bilirubin less than 3 times the upper limits of normal and Aspartate transaminase (AST) less than 5 times the upper limits of normal.
11.No other systemic anti-cancer therapy during the study, except corticosteroid medication, or radiotherapy to non-indicator sites of disease.
12.Women of child-bearing potential must be practising barrier or oral contraception, for the duration of the study, or documented as surgically sterile or one year post-menopausal.
13.If female, be non-nursing, non-pregnant.
14.Given informed consent.
Minimum age
17 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Presence of any one of the following will exclude the patient from study:

1.Eastern Cooperative Oncology Group (ECOG) performance status 3 or less.
2.Clinically significant infection defined as any acute viral, bacterial or fungal infection which requires specific therapy. Anti-infection therapy must have been completed within 14 days of starting study treatment (except for infections acquired during therapy).
3.Ocular melanoma as the primary lesion.
4 Life expectancy less than 3 months.

Study design
Defined population
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3577 0
Government body
Name [1] 3577 0
Cancer Institute
Address [1] 3577 0
Tehcnology Park
Redfern NSW
Country [1] 3577 0
Primary sponsor type
Government body
Cancer Institute
Technology Park
Secondary sponsor category [1] 3213 0
Name [1] 3213 0
Address [1] 3213 0
Country [1] 3213 0

Ethics approval
Ethics application status
Ethics committee name [1] 5619 0
Sydney South West Area Health Service
Ethics committee address [1] 5619 0
Missenden Rd
Camperdown NSW
Ethics committee country [1] 5619 0
Date submitted for ethics approval [1] 5619 0
Approval date [1] 5619 0
Ethics approval number [1] 5619 0

Brief summary
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 28652 0
Address 28652 0
Country 28652 0
Phone 28652 0
Fax 28652 0
Email 28652 0
Contact person for public queries
Name 11809 0
Margaret Lett
Address 11809 0
level 2
Eden St
North Sydney NSW2060
Country 11809 0
Phone 11809 0
Fax 11809 0
Email 11809 0
Contact person for scientific queries
Name 2737 0
Graham Mann
Address 2737 0
Millinium Institute
Country 2737 0
Phone 2737 0
Fax 2737 0
Email 2737 0

No information has been provided regarding IPD availability
Summary results
No Results