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| ITEM - a phase II Study of ImaTinib in the treatment of patients with metastatic uvEal Melanoma |
| Source of record | UK Trials |
| ISRCTN | ISRCTN91548930 |
| Date ISRCTN assigned | 13/02/2008 |
| Local reference number(s) | CCO2007/18 |
| Public title | ITEM - a phase II Study of ImaTinib in the treatment of patients with metastatic uvEal Melanoma |
| Scientific title | A single arm, multi-centre, two stage, phase II study of imatinib in good performance status patients with c-kit positive metastatic melanoma |
| Acronym | ITEM |
| Disease/condition/study domain | Metastatic eye melanoma |
| Study hypothesis | To determine the efficacy of imatinib in patients with metastatic uveal melanoma based upon standard radiological and positron emission tomography (PET)/computed tomography (CT) response. |
| Design/methodology | A single arm, multicentre, two stage, phase II study |
| Research ethics review | The MREC application will be submitted to Bolton Research Ethics Committee on 28th January 2008 for the meeting scheduled for 11th February: approval pending. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 01/04/2010 |
| Status of trial | Ongoing |
| Target number of participants | The trial will adopt a two-stage Gehan design enrolling 14 patients in the first stage, reaching a maximum of 25 patients |
| Interventions | This is a single arm phase II study. Stored tissue of primary ocular tumour and/or metastatic biopsies will be collected at baseline to determine eligibility and will be available for associated translational research. All patients will be asked to consent for collection of serum samples at baseline. All patients will receive imatinib 400 mg to be taken by mouth once a day. Patients will be followed up every 28 days for toxicity and will remain on study drug until disease progression, death, unacceptable toxicity or patient choice. CT will be at baseline and at weeks 6 and 12 with 8 weekly scans thereafter. PET will be in selected centres at baseline, week 6 and 12. Patients will be followed until death for overall survival. |
| Primary outcome measure(s) | The primary outcome is progression-free survival at 3 months. |
| Secondary outcome measure(s) | 1. Objective response rate, according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria, assessed every 8 weeks 2. Overall survival (OS) assessed at date of first treatment to date of death and safety and toxicity, assessed every 28 days 3. Biomarker correlation with outcome measures 4. PET response (European Organisation for Research and Treatment of Cancer [EORTC] guidelines, Young, 1999) |
| Trial website | http://www.lctu.org.uk/trial/ITEM.html |
| Sources of funding | Cancer Research UK (UK) (Ref: C1810/A9396) |
| Sponsor name | Clatterbridge Centre for Oncology NHS Foundation Trust (UK) |
| Sponsor details | Clatterbridge Road Bebington, Wirral Merseyside United Kingdom CH63 4JY |
| Sponsor telephone | +44 (0)151 334 1155 |
| Sponsor fax | +44 (0)151 482 7806 |
| Sponsor email | Gill.Sims@ccotrust.nhs.uk |
| Sponsor website | http://www.ccotrust.nhs.uk/ |
| Contact name | Dr Ernist Marshall |
| Contact details | Clatterbridge Centre for Oncology NHS Foundation Trust Clatterbrige Road Bebington, Wirral Merseyside United Kingdom CH63 4JY |
| Contact telephone | +44 (0)151 482 7801 |
| Contact fax | +44 (0)151 482 7621 |
| Contact email | emarshall@nhs.net |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN91548930 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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