Clinical trial NCT00749684: Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: interferon-alpha
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants in Austria with malignant melanoma at high risk of relapse

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Disease Recurrence
timeFrame: Throughout 12 months of treatment and 24 months of follow-up
measure: Relapse Free Survival Time
timeFrame: Throughout 12 months of treatment and 24 months of follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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