Clinical trial NCT00002892: Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma
Official title: A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma (Skin)
Keywords: stage II melanoma
stage III melanoma
recurrent melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-05-13
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hampstead, London
country: United Kingdom
facility: Royal Free Hospital
state: England
city: Leeds
country: United Kingdom
facility: St. James's Hospital
state: England
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: England
city: London
country: United Kingdom
facility: Guy's, King's and St. Thomas' Hospitals Trust
state: England
city: London
country: United Kingdom
facility: Royal Marsden NHS Trust
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital N.H.S. Trust
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Birmingham
country: United Kingdom
facility: Selly Oak Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Southend on Sea
country: United Kingdom
facility: Southend Hospital
Study officials:
affiliation: Cancer Research Centre at Weston Park Hospital
name: Barry W. Hancock, MD
role: STUDY_CHAIR
References:
citation: 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.