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ITEM   

Title

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


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
II Treatment FollowUp Over 18 Clatterbridge Centre for Oncology Eudract No: 2007-006216-39

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.


Trial Lead Organisations

  • Clatterbridge Centre of Oncology
  • Chief Investigator: Dr E Marshall


Trial Start Date

19/08/2008


Trial Coordinator

Matthew Bickerstaff


Trial Coordinator Email Address

oasis@liverpool.ac.uk


Trial Coordinator Contact No

0151 794 8934


Website Treatment  

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 Endpoints  

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

Eligibility  

  • 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.

UK: ENGLAND

  • Leeds, St. James's University Hospital (Leeds) (Maria Marples)
  • Northwood, Mount Vernon Hospital (Northwood) (Paul Nathan)
  • Sheffield, Weston Park Hospital (Sheffield) (Barry Hancock)
  • Wirral, The Clatterbridge Cancer Centre (Wirral) (Ernie Marshall)

Links  

../docs/Leaflets/item.pdf#ITEM leaflet