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Trial registered on ANZCTR


Registration number
ACTRN12608000327381
Ethics application status
Approved
Date submitted
6/06/2008
Date registered
15/07/2008
Date last updated
15/07/2008
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

Intervention/exposure
Study type
Observational
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 (www.nhgri.nih.gov/DIR/microarray), 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
Uncontrolled

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3577 0
Government body
Name [1] 3577 0
Cancer Institute
Country [1] 3577 0
Australia
Primary sponsor type
Government body
Name
Cancer Institute
Address
Technology Park
Redfern
Country
Australia
Secondary sponsor category [1] 3213 0
None
Name [1] 3213 0
Address [1] 3213 0
Country [1] 3213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5619 0
Sydney South West Area Health Service
Ethics committee address [1] 5619 0
Ethics committee country [1] 5619 0
Australia
Date submitted for ethics approval [1] 5619 0
19/10/2000
Approval date [1] 5619 0
19/12/2000
Ethics approval number [1] 5619 0

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

Contacts
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
Australia
Phone 11809 0
0299117304
Fax 11809 0
0299549435
Email 11809 0
margaret.lett@smu.org.au
Contact person for scientific queries
Name 2737 0
Graham Mann
Address 2737 0
Millinium Institute
Westmead
Country 2737 0
Australia
Phone 2737 0
98459056
Fax 2737 0
Email 2737 0
gmann@mail.usyd.edu.au

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.