Chemosensitivity
A study of the molecular profile of melanoma chemosensitivity and resistance in patients undergoing intravenous limb infusion for metastatic melanoma.
Contact person: Margaret Lett, SMU phone: 02 9911 7304 or 02 9515 8880 and use pager number 88893 following the prompts.
INCLUSION CRITERIA
- Age: 17 years and over.
- There must be two or more bidimensionally measurable masses evaluated using the metric system, taken within 1 week of the on-study date.
- 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.
- Life expectancy 3 months or more able to undergo routine outpatient evaluations.
- Clinically adequate haematological, bone marrow, kidney, cardiac, liver function.
- Serum creatinine less than or equal to 180 umol/L. Serum bilirubin less than 3 times the upper limits of normal and AST (ASAT or ALAT) less than 5 times the upper limits of normal.
- No other systemic anti-cancer therapy during the study, except corticosteroid medication, or radiotherapy to non-indicator sites of disease.
- 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. If female, be non-nursing, non-pregnant
EXCLUSION CRITERIA
Presence of any one of the following will exclude the patient from study:
- ECOG performance status 3 or less.
- Clinically significant infection defined as any acute viral, bacterial or fungal infection which requires specific therapy. Antiinfection therapy must have been completed within 14 days of starting study treatment (except for infections acquired during therapy).
- Ocular melanoma as the primary lesion.
- Life expectancy less than 3 months.
