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NCT00002892 Clinical Trial

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

Melanoma (Skin) Clinical Trial

Official title:
A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA

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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