Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.
Observational study to evaluate the tolerability and efficacy (vs historical controls) of a
high-dose therapy scheme with interferon-α-2b (IntronA®):
Adjuvant treatment with interferon-α-2 has been demonstrated in a number of studies to have
an antiproliferative effect on malignant melanoma. In these cases a response rate of up to
20% could be achieved with a dose of 10 million IU or more 3x/week or daily. Kirkwood et al.
showed in a study carried out in ECOG (the Eastern Cooperative Oncology Group, study no.
1684) that there was a clear and significant survival advantage versus the observation group
with the following dose:
20 mio IU/m² interferon-α-2b (IntronA®) 5x/week iv over the course of one month followed by
11 months with 10 mio IU/m² 3x/week sc.
Observational Model: Cohort, Time Perspective: Prospective
Number of Participants With Disease Recurrence
Number of participants with disease recurrence was being measured.
Throughout 12 months of treatment and 24 months of follow-up
Austria: Agency for Health and Food Safety