Skin cancer Cancer Skin
Conditions
Interventions
Patients are randomised to one of two treatment arms:
1. Arm A: Interferon alpha-2a 3MU three times per week until recurrence, or for 2 years.
2. Arm B: No further treatment.
Sponsors
Roche Products Limited (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven malignant melanoma and high risk of recurrent metastatic disease will be eligible for the present study. This will include patients with either: a. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at initial presentation b. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at subsequent presentation c. Non-nodal superficial regional recurrence (local or in-transit disease) d. Primary tumours 4 mm or more Breslow thickness without any other detectable focus of metastasis 2. Fit to receive interferon 3. Wound healed following surgery 4. Clinically disease-free 5. No history of other malignant disease, except previously cured early carcinoma of the cervix or skin 6. No previous biological therapy 7. Not on systemic steroids or other immunosuppressive therapy 8. Not pregnant, lactating or intending pregnancy during treatment 9. Less than 12 weeks since resection
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed