None listed
Conditions
Brief summary
People with melanoma that has spread from the skin to the lymph nodes or internal organs respond differently to chemotherapy drugs. But it often takes several months of chemotherapy to determine if a particular drug is working. The aim of this study is to see whether doing tests on a tumour that has been removed from the body after 1 cycle of chemotherapy can help predict if an individual will benefit from that chemotherapy.
Interventions
Biopsies of in transit lesions (x2 mandatory 1 pre treatment and the other 7 days post treatment) and up to 4 optional biopsies possible at 14, 21, 28 & 56 days post treatment
Bloods will be collected at the following intervals: Baseline = Full Blood Count (FBC), Electrolytes, Urea & Creatinine (EUC), Liver Function Tests (LFTs), Lactate Dehydrogenase (LDH), International Normalised Ratio (INR), Activated Partial Thromboplastin Time (APTT), serum storage, flow cytometry & Deoxyribonucleic acid (
Biopsies of in transit lesions (x2 mandatory 1 pre treatment and the other 7 days post treatment) and up to 4 optional biopsies possible at 14, 21, 28 & 56 days post treatment Bloods will be collected at the following intervals: Baseline = Full Blood Count (FBC), Electrolytes, Urea & Creatinine (EUC), Liver Function Tests (LFTs), Lactate Dehydrogenase (LDH), International Normalised Ratio (INR), Activated Partial Thromboplastin Time (APTT), serum storage, flow cytometry & Deoxyribonucleic acid (DNA) & Ribonucleic acid (RNA) extraction Days 7, 14 & 21 = FBC, serum storage & flow cytometry Days 28 & 56 = FBC, serum storage, flow cytometry & DNA/RNA extraction Expected study duration 18 months
Sponsors
Sydney South West Area Health Service RPA Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
Life expectancy of at least 2 months; Eastern Cooperative Oncology Group (ECOG) performance status score 0-3; Histologic or cytologic diagnosis of unresectable Stage IV malignant melanoma; Required values for initial laboratory tests: White Blood Count (WBC) = 3000 x 103/mL; Absolute Neutrophil Count (ANC) = 1500 x 103/mL; Platelets = 90 x 106/mL; Haemoglobin = 9 g/dL; Aspartate aminotransferase (AST) = 3 x Upper Limit of normal (ULN) for patients without liver metastasis; = 5 x Upper Limit of normal (ULN) for patients with liver metastasis; Bilirubin = 2 x Upper Limit of normal (ULN), (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/mL); Creatinine = 1.5 x Upper Limit of normal (ULN); At least 4 weeks post chemotherapy (at least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin), immunotherapy, hormonal therapy, or major surgery and the beginning of protocol therapy.
Exclusion criteria
Metastatic ocular melanoma; Symptomatic, untreated central nervous system (CNS) metastasis; Use of any immunosuppressing treatments including corticosteroids (patients on stable doses of hormone replacement therapy are exempt), cyclosporine, mycophenolate mofetil, chemotherapy, radiation, etc, within 4 weeks prior to Day 1 of treatment; Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or Stage I carcinoma of the prostate; Concomitant therapy with any of the following: IL-2, interferon or other non-study anti-melanoma immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (patients on stable doses of hormone replacement therapy are exempt).
Outcome results
None listed