Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)
|ClinicalTrials.gov Identifier: NCT00749684|
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : March 24, 2011
Last Update Posted : October 19, 2015
|Condition or disease||Intervention/treatment|
|Melanoma||Biological: Interferon α-2b|
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.
|Study Type :||Observational|
|Actual Enrollment :||138 participants|
|Official Title:||Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.|
|Study Start Date :||December 1996|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2009|
Adults with malignant melanoma at high risk of relapse
Adults with malignant melanoma of the following stages:
Biological: Interferon α-2b
20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months.
Other Name: Intron A
- Number of Participants With Disease Recurrence [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ]Number of participants with disease recurrence was being measured.
- Relapse Free Survival Time [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ]Median time to recurrence according to Kaplan Maier evaluation