Melanoma Clinical Trial
Official title:
Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.
The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control).
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
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