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ISRCTN
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ISRCTN13456221
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ClinicalTrials.gov identifier
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Public title
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A Randomised Study of Observation versus Adjuvant Low Dose Extended Duration Interferon Alpha-2a in High Risk Resected Malignant Melanoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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AIM HIGH
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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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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Skin cancer
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Participants - inclusion criteria
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1. Patients with histologically proven malignant melanoma and high risk of recurrent metastatic disease will be eligible for the present study. This will include patients with either:
a. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at initial presentation
b. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at subsequent presentation
c. Non-nodal superficial regional recurrence (local or in-transit disease)
d. Primary tumours 4 mm or more Breslow thickness without any other detectable focus of metastasis
2. Fit to receive interferon
3. Wound healed following surgery
4. Clinically disease-free
5. No history of other malignant disease, except previously cured early carcinoma of the cervix or skin
6. No previous biological therapy
7. Not on systemic steroids or other immunosuppressive therapy
8. Not pregnant, lactating or intending pregnancy during treatment
9. Less than 12 weeks since resection
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2000
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Anticipated end date
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22/12/2000
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Status of trial
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Completed
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Patient information material
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Target number of participants
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674
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Interventions
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Patients are randomised to one of two treatment arms:
1. Arm A: Interferon alpha-2a 3MU three times per week until recurrence, or for 2 years.
2. Arm B: No further treatment.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Roche Products Ltd
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14665609
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Sponsor
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Roche Products Limited (UK)
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Address
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P.O. Box 8
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City/town
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Welwyn Garden City, Hertfordshire
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Zip/Postcode
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AL7 3AY
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Country
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United Kingdom
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Sponsor website:
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http://www.roche.com
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Date applied
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19/08/2002
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Last edited
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17/12/2007
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Date ISRCTN assigned
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19/08/2002
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