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Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.

18 Years
70 Years
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Trial Information

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.

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

- 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

- 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

- Participants on corticosteroid treatment or treatment with an immunomodulating

- 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)

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of Participants With Disease Recurrence

Outcome Description:

Number of participants with disease recurrence was being measured.

Outcome Time Frame:

Throughout 12 months of treatment and 24 months of follow-up

Safety Issue:



Austria: Agency for Health and Food Safety

Study ID:




Start Date:

September 1996

Completion Date:

September 2009

Related Keywords:

  • Melanoma
  • interferon-alpha
  • Melanoma