Interferon Alfa or No Further Therapy Following Surgery in NCT00002892

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002892
Other study ID #	CDR0000065215
Secondary ID	NCRI-AIM-HIGHEU-
Status	Completed
Phase	Phase 3
First received	November 1, 1999
Last updated	December 18, 2013
Start date	October 1995
Est. completion date	December 2001

Study information
Verified date	May 2007
Source	National Cancer Institute (NCI)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Determine the effects of adjuvant low-dose extended-duration interferon alfa on disease-free and overall survival in patients with completely resected malignant melanoma at high risk of recurrence. II. Determine any correlation between patient age or sex and the effects of interferon therapy on disease-free and overall survival. III. Describe the toxic effects of this treatment. IV. Evaluate the economic implications of implementing effective interferon therapy in these patients.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	1000
Est. completion date	December 2001
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma definitively resected within 12 weeks prior to entry One of the following categories: Stage II disease (greater than 4 mm Breslow thickness) Stage III disease (regional lymph node involvement) Recurrent non-nodal superficial regional disease (local or in transit) Recurrent regional nodal involvement 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• recombinant interferon alfa

Locations
Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Selly Oak Hospital	Birmingham
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Royal Free Hospital	Hampstead, London	England
United Kingdom	Queen Elizabeth Hospital	King's Lynn
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	Salisbury District Hospital	Salisbury
United Kingdom	Weston Park Hospital	Sheffield	England
United Kingdom	Southend Hospital	Southend on Sea

Sponsors *(1)*
Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom,

References & 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 — View Citation

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Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma

Clinical Trial Details — Status: Completed

Administrative data

Study information