Molecular Profile of Melanoma Chemosensitivity and Resistance
- Conditions
- Metastatic MelanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12608000327381
- Lead Sponsor
- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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.
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[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 Measures
Name Time Method By microarray analysis, to determine the molecular profile of expressed molecules in the circulating T-lymphocytes.[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.];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.[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.]