Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)

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.

Inclusion criteria

• Male and female participants
• Age 18-70 years
• Malignant melanoma stage II or III (>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
• An excision border of at least 2 cm around the primary tumor
• Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
• ECOG status 0-1 (= Karnofsky Index >/= 80)
• Laboratory parameters

• Hematocrit >= 33%
• Leukocytes >= 3000/μl
• Thrombocytes >= 100000/μl
• Alanine aminotransferase(ALT) <= 2x normal values
• Bilirubin <= 2x normal values

Exclusion criteria

• Known allergy to one of the medications or any of its component parts
• Refusal on the part of participants capable of childbearing to use a reliable contraceptive
• Lactating mothers
• Presence of distant metastases
• Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is > 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
• Participants on corticosteroid treatment or treatment with an immunomodulating substance
• Preexisting psychiatric illness, particularly serious depression
• Prior adjuvant radio-, chemo-, or immuno-therapy
• Treatment with an investigational drug within the prior 30 days
• Participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration
• Myocardial infarction within the prior year
• An unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study
• Psoriasis (a relative exclusion criterion, since interferon can aggravate psoriasis; decision to be based on risk/benefit analysis)