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ISRCTN
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ISRCTN91548930
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ClinicalTrials.gov identifier
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Public title
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ITEM - a phase II Study of ImaTinib in the treatment of patients with metastatic uvEal Melanoma
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Scientific title
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A single arm, multi-centre, two stage, phase II study of imatinib in good performance status patients with c-kit positive metastatic melanoma
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Acronym
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ITEM
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Serial number at source
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CCO2007/18
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Study hypothesis
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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.
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Ethics approval
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Added 06/02/2009: Bolton Research Ethics Committee gave approval on the 30th June 2008 (ref: 08/H1010/21)
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Study design
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Single arm, multicentre, two stage, phase II study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Metastatic eye melanoma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2008
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Anticipated end date
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01/04/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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The trial will adopt a two-stage Gehan design enrolling 14 patients in the first stage, reaching a maximum of 25 patients
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Interventions
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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.
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Primary outcome measure(s)
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The primary outcome is progression-free survival at 3 months.
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Secondary outcome measure(s)
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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)
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Sources of funding
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Cancer Research UK (CRUK) (UK) (ref: C1810/A9396)
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Trial website
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http://www.lctu.org.uk/trial/ITEM.html
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Publications
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Contact name
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Dr
Ernist
Marshall
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Address
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Clatterbridge Centre for Oncology NHS Foundation Trust
Clatterbrige Road
Bebington, Wirral
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City/town
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Merseyside
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Zip/Postcode
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CH63 4JY
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Country
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United Kingdom
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Tel
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+44 (0)151 482 7801
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Fax
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+44 (0)151 482 7621
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Email
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emarshall@nhs.net
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Sponsor
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Clatterbridge Centre for Oncology NHS Foundation Trust (UK)
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Address
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Clatterbridge Road
Bebington, Wirral
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City/town
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Merseyside
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Zip/Postcode
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CH63 4JY
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Country
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United Kingdom
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Tel
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+44 (0)151 334 1155
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Fax
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+44 (0)151 482 7806
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Email
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Gill.Sims@ccotrust.nhs.uk
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Sponsor website:
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http://www.ccotrust.nhs.uk/
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Date applied
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18/01/2008
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Last edited
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06/02/2009
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Date ISRCTN assigned
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13/02/2008
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