Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Free Hospital | Hampstead, London | England | United Kingdom | NW3 2QG |
| 2 | St. James's Hospital | Leeds | England | United Kingdom | LS9 7TF |
| 3 | University Hospitals of Leicester | Leicester | England | United Kingdom | LE1 5WW |
| 4 | Guy's, King's and St. Thomas' Hospitals Trust | London | England | United Kingdom | SE1 7EH |
| 5 | Royal Marsden NHS Trust | London | England | United Kingdom | SW3 6JJ |
| 6 | Christie Hospital N.H.S. Trust | Manchester | England | United Kingdom | M20 4BX |
| 7 | Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | United Kingdom | L63 4JY |
| 8 | Weston Park Hospital | Sheffield | England | United Kingdom | S1O 2SJ |
| 9 | Aberdeen Royal Infirmary | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
| 10 | Selly Oak Hospital | Birmingham | United Kingdom | B29 6JD | |
| 11 | Royal Bournemouth Hospital | Bournemouth | United Kingdom | BH7 7DW | |
| 12 | Queen Elizabeth Hospital | King's Lynn | United Kingdom | PE30 4ET | |
| 13 | Salisbury District Hospital | Salisbury | United Kingdom | SP2 8BJ | |
| 14 | Southend Hospital | Southend on Sea | United Kingdom | SS0 0RY |
Sponsors and Collaborators
- Institute of Cancer Research, United Kingdom
Investigators
- Study Chair: Barry W. Hancock, MD, Cancer Research Centre at Weston Park Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000065215
- NCRI-AIM-HIGH
- EU-96052
- UKCCCR-AIM-HIGH