ITEM
Title
ITEM: A Phase II Study of Imatinib in the Treatment of Patients with Metastatic Uveal Melanoma
Basic Trial Information
| Phase | Type | Status | Sponsor | Protocol IDs |
| II | Treatment | Closed | Clatterbridge Centre for Oncology | EUDRACT No: 2007-006216-39 ISRCTN No: |
Trial Description
Purpose
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.
Latest Update
- Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (c-kit positive on IHC; for the purposes of this exploratory study, any IHC positivity will be allowed although a description of pattern will be presented)
- Any prior therapy for advanced disease excluding agents targeting c-kit.
- Life expectancy > 12 weeks,
- Performance status 0, 1 or 2 (ECOG performance scale : Appendix A).
- Presence of 1 or more measurable lesions, either clinically or radiologically, using RECIST criteria.
- Age > 18 years
- Adequate haematological, renal and liver function as defined below and performed within 14 days of study inclusion:
- Written informed consent provided by the patient
- Women of child-bearing potential must have a negative pregnancy test prior to study entry and be using adequate contraception, which must be continued for 12 months after the study
- Prior radiotherapy is allowed. However, measurable lesions must not have been previously irradiated.
- Patients must not have a history of other malignant disease other than adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix.
Treatment/Intervention
A Phase II, UK based study of Imatinib in the treatment of patients with metastatic uveal melanoma. The trial aims to recruit 25 patients who will be treated with Imatinib orally until disease progression or toxicity. The trial is hoping to open in April 2008 and will run for two years. The trial is a multi centre trial across four centres.
Trial Endpoint
To evaluate the 3 month progression free rate of patients with unresectable good performance c-kit positive metastatic uveal melanoma treated with Imatinib
Primary Outcome
- Progression free survival at 3 months
Secondary outcomes
- Safety and toxicity of Imatinib
- Progression free survival (overall)
- Overall survival
- Overall response rate (according to RECIST criteria)
- Biomarker correlation with outcome measures
Trial Lead Organisations
- Clatterbridge Centre of Oncology
- Chief Investigator: Dr E Marshall
Registry Information
Official Title
ITEM: A Phase II Study of Imatinib in the Treatment of Patients with Metastatic Uveal Melanoma
Links & other information
Trial Start Date
19/08/2008
