TEAM
Biomarker evaluation of short-term administration of chemotherapeutic or biologic agents in patients with unresectable Stage IIIb, IIIc or IV melanoma amenable to pre- and post-treatment biopsy.
Contact person: Maria Cronin, SMU North Sydney phone: 02 9911 7302 maria.cronin@smu.org.au
Amie Cho, Westmead phone: 02 9845 7670 Amie.cho@swahs.health.nsw.gov.au or Dr Georgina Long - glong@med.usyd.edu.au
INCLUSION CRITERIA
1. Target population
- Compliance with visits/procedures. Life expectancy of at least 3 months.
- ECOG performance status score 0-2.
- Histologic or cytologic diagnosis of unresectable Stage IIIb, IIIc or IV malignant melanoma (excluding ocular melanoma).
- A pre- and post-treatment fresh tumour biopsy must be provided for biomarker and predictive marker analyses.
- At least 3 weeks must have elapsed since the last chemotherapy or immunotherapy (at least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin), and the beginning of protocol therapy.
- Prior radiation therapy is allowed but not to sites of planned biopsy.
- Toxicity related to prior therapy must either have returned to ≤ grade 1, baseline, or been deemed irreversible.
- By participating in this study, patients should not be compromised in terms of participation in any currently open clinical trials for which they are otherwise eligible. Men and women, ages 18 and above.
EXCLUSION CRITERIA
Target disease exclusion
- 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
- Metastatic ocular melanoma
Medical history and concurrent diseases
- Symptomatic, untreated central nervous system (CNS) metastasis;
Prohibited therapies and/or medications
- Exposure to any other investigational drug or placebo during the treatment
phase of study (Day 0-28) or within 4 weeks prior to start of treatment (Day 0). - Concomitant therapy with any of the following: IL-2, interferon or other nonstudy anti-melanoma immunotherapy regimens; cytotoxic chemotherapy or other investigational therapies.
Regimen-specific exclusion criteria
- Known HIV positivity
Please note: Reproductive status is not an exclusion criteria for this study however patients will conform with the reproductive eligibility requirements for the systemic treatment they are receiving.
