Trials / Completed
CompletedNCT00002892
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- Institute of Cancer Research, United Kingdom · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | recombinant interferon alfa |
Timeline
- Start date
- 1995-10-01
- Completion
- 2001-12-01
- First posted
- 2004-05-13
- Last updated
- 2013-12-19
Locations
14 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00002892. Inclusion in this directory is not an endorsement.