ITEM - a phase II study of imatinib in the treatment of patients with metastatic uveal melanoma

ISRCTN	ISRCTN91548930
DOI	https://doi.org/10.1186/ISRCTN91548930
Clinical Trials Information System (CTIS)	2007-006216-39
Protocol serial number	CCO2007/18
Sponsor	Clatterbridge Centre for Oncology NHS Foundation Trust (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C1810/A9396)

Submission date: 18/01/2008
Registration date: 13/02/2008
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-imatinib-for-melanoma-of-the-eye-that-has-spread

Contact information

Dr Ernist Marshall
Scientific

Clatterbridge Centre for Oncology NHS Foundation Trust
Clatterbrige Road
Bebington, Wirral
Merseyside
CH63 4JY
United Kingdom

Phone	+44 (0)151 482 7801
Email	emarshall@nhs.net

Study information

Primary study design	Interventional
Study design	Single arm, multicentre, two stage, phase II study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	ITEM
Study objectives	The aim of this study is 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.
Ethics approval(s)	Added 06/02/2009: Bolton Research Ethics Committee gave approval on the 30th June 2008 (ref: 08/H1010/21)
Health condition(s) or problem(s) studied	Metastatic eye melanoma
Intervention	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.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Imatinib
Primary outcome measure(s)	Progression-free survival at 3 months.
Key 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)
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex
Target sample size at registration	25
Total final enrolment	25
Key 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
Key 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
Date of first enrolment	01/04/2008
Date of final enrolment	01/04/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Clatterbridge Centre for Oncology NHS Foundation Trust

Merseyside
CH63 4JY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
29/03/2018: Conference proceedings added to publication and dissemination plan.
29/02/2016: No publications found, verifying study status with principal investigator.