ITEM - a phase II study of imatinib in the treatment of patients with metastatic uveal melanoma
- Conditions
- Metastatic eye melanomaCancerEye melanoma
- Registration Number
- ISRCTN91548930
- Lead Sponsor
- Clatterbridge Centre for Oncology NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
1. Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (c-kit positive on immunohistochemistry [IHC])
2. Any prior therapy for advanced disease excluding agents targeting c-kit
3. Life expectancy greater than 12 weeks
4. World Health Organization (WHO) performance status 0, 1 or 2
5. Presence of one or more measurable lesions
6. Age greater than 18 years, either sex
7. Adequate haematological, renal and liver function
8. Written informed consent provided by the patient
1. C-kit negative uveal melanoma
2. Any previous investigational agent within the last 12 weeks
3. Known leptomeningeal or brain metastases
4. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
5. Any medical or psychiatric condition which would influence the ability to provide informed consent
6. Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival at 3 months.
- Secondary Outcome Measures
Name Time Method <br> 1. Objective response rate, according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria, assessed every 8 weeks<br> 2. Overall survival (OS) assessed at date of first treatment to date of death and safety and toxicity, assessed every 28 days<br> 3. Biomarker correlation with outcome measures<br> 4. PET response (European Organisation for Research and Treatment of Cancer [EORTC] guidelines, Young, 1999)<br>