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Clinical Trials > Melanoma

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ITEM ITEM: A Phase II Study of Imatinib in the Treatment of Patients with Metastatic Uveal Melanoma

Uveal melanoma is the most common primary malignancy involving the eye, but remains rare, with an annual age-adjusted incidence of around 7 per million of the population1. Ocular melanomas can involve any part of the uveal tract i.e. the choroid, ciliary body or iris. On clinical, biological and molecular grounds, uveal melanoma is a separate disease distinct from cutaneous melanoma. Approximately 5% of patients present with metastatic disease. A further 30-50% develop metastatic disease, usually within 3 years of primary treatment2. There is no effective systemic therapy for metastatic uveal melanoma. Furthermore, few clinical trials have been conducted, and those which have, often involve small numbers of patients.
NITRO Neo-adjuvant IntraviTreal Ranibizumab treatment in high risk Ocular melanoma patients: A two stage single centre Phase II single arm study.

Uveal melanomas have an estimated incidence of 6 per million per year. The average age at presentation is 59 years and there is no gender preponderance. Approximately 40% of all patients die of metastatic disease, which usually involves the liver. This devastating prognosis has remained unchanged over the last 30 years. For many years the standard treatment was removal of the eye, but this radical treatment has been superseded by a variety of methods aimed at conserving the eye and useful vision. In about 30% of patients, eye-conserving treatments are not considered appropriate, because of large tumour size, optic nerve involvement, extensive involvement of ciliary body or iris, or bulky extraocular spread. Such are treated by eye removal. Loss of the eye diminishes quality of life, causing facial deformity and, in some patients, visual handicap. There is scope for reducing the rate of eye removal. One approach would be to reduce tumour size by administering a first step therapy, so that some form of eye-conservative therapy can be administered with a reasonable chance of success.
SelPac A Randomised three-arm, open label, Phase II study of continuous Selumetinib versus continuous or interrupted Selumetinib in combination with weekly Paclitaxel in Metastatic Uveal Melanoma.

SUAVE A randomised phase II study of Sunitinib versus Dacarbazine in the treatment of patients with metastatic uveal melanoma ** Recruitment is on-hold as of 08 November 2012

Uveal melanoma is the most common primary malignancy involving the eye, but remains rare, with an annual age-adjusted incidence of around 7 per million of the population. Uveal melanoma is characterised by an unpredictable clinical course and a tendency to metastasise late. Even so, overall prognosis is significantly worse than for cutaneous melanoma, with 5 and 15 year survival rates of 72% and 53% respectively. Local control can be achieved using various radiotherapy techniques or enucleation of the affected eye. However once local control is lost, the disease is incurable. No adjuvant therapy has demonstrated any survival benefit. Approximately 5% of patients present with metastatic disease. A further 30-50% develop metastatic disease, usually within 3 years of primary treatment. In metastatic patients, the median survival varies from 2-6 months with only 15% of patients surviving more than a year.
There is no effective systemic therapy for metastatic uveal melanoma. Furthermore, few clinical trials have been conducted and those which have often involve small numbers of patients. The lack of activity noted to date point to an urgent need to investigate novel therapies in this disease.

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