Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma
A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA
4 other identifiers
interventional
1,000
1 country
14
Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known whether interferon alfa following surgery is more effective than surgery alone in treating patients with melanoma. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 1995
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedFirst Posted
Study publicly available on registry
May 13, 2004
CompletedDecember 19, 2013
May 1, 2007
November 1, 1999
December 18, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (14)
Royal Free Hospital
Hampstead, London, England, NW3 2QG, United Kingdom
St. James's Hospital
Leeds, England, LS9 7TF, United Kingdom
University Hospitals of Leicester
Leicester, England, LE1 5WW, United Kingdom
Guy's, King's and St. Thomas' Hospitals Trust
London, England, SE1 7EH, United Kingdom
Royal Marsden NHS Trust
London, England, SW3 6JJ, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY, United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Selly Oak Hospital
Birmingham, B29 6JD, United Kingdom
Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET, United Kingdom
Salisbury District Hospital
Salisbury, SP2 8BJ, United Kingdom
Southend Hospital
Southend-on-Sea, SS0 0RY, United Kingdom
Related Publications (1)
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.
PMID: 14665609RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Barry W. Hancock, MD
Cancer Research Centre at Weston Park Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 1, 1999
First Posted
May 13, 2004
Study Start
October 1, 1995
Study Completion
December 1, 2001
Last Updated
December 19, 2013
Record last verified: 2007-05