Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma
NCT ID: NCT00002892
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
1995-10-31
2001-12-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage II, stage III, or recurrent melanoma.
Detailed Description
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OUTLINE: This is a randomized study. Patients will be stratified by age, sex, disease status at entry, and participating institution. Patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until disease progression or toxicity intervenes. Patients are followed monthly for 6 months, quarterly for 18 months, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be entered over 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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recombinant interferon alfa
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Able to tolerate interferon No second malignancy except curatively treated: Carcinoma of the cervix Nonmelanomatous skin cancer No pregnant or nursing women
PRIOR CONCURRENT THERAPY: No prior immunosuppressive therapy, including systemic steroids No prior biologic therapy Recovered from surgery
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Principal Investigators
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Barry W. Hancock, MD
Role: STUDY_CHAIR
Cancer Research Centre at Weston Park Hospital
Locations
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Royal Free Hospital
Hampstead, London, England, United Kingdom
St. James's Hospital
Leeds, England, United Kingdom
University Hospitals of Leicester
Leicester, England, United Kingdom
Guy's, King's and St. Thomas' Hospitals Trust
London, England, United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Selly Oak Hospital
Birmingham, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Queen Elizabeth Hospital
Kings Lynn, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
Southend Hospital
Southend-on-Sea, , United Kingdom
Countries
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References
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Hancock BW, Wheatley K, Harris S, Ives N, Harrison G, Horsman JM, Middleton MR, Thatcher N, Lorigan PC, Marsden JR, Burrows L, Gore M. Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma. J Clin Oncol. 2004 Jan 1;22(1):53-61. doi: 10.1200/JCO.2004.03.185. Epub 2003 Dec 9.
Other Identifiers
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NCRI-AIM-HIGH
Identifier Type: -
Identifier Source: secondary_id
EU-96052
Identifier Type: -
Identifier Source: secondary_id
UKCCCR-AIM-HIGH
Identifier Type: -
Identifier Source: secondary_id
CDR0000065215
Identifier Type: -
Identifier Source: org_study_id