Biomarker evaluation of short-term administration of chemotherapeutic or biologic agents in patients with unresectable Stage IV melanoma amenable to pre- and post-treatment biopsy.

Not Applicable

Recruiting

• Conditions: Melanoma; Skin - Dermatological conditions

• Registration Number: ACTRN12607000510448
• Lead Sponsor: Sydney South West Area Health Service RPA Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if short-term administration drug therapy produces histological, immunological and molecular changes in melanoma indicative of potential anti-tumour activity. Where present, such changes may assist in the selection of agents for more extensive clinical testing alone and in combination with other drugs.[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<br>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<br>Days 7, 14 & 21 = FBC, serum storage & flow cytometry<br>Days 28 & 56 = FBC, serum storage, flow cytometry & DNA/RNA extraction]