None listed
Conditions
Interventions
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 i
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)
Sponsors
Cancer Institute
Eligibility
Sex/Gender
All
Age
17 Years to 85 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed