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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749684
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : March 24, 2011
Last Update Posted : October 19, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment
Melanoma Biological: Interferon α-2b

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.

Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Group/Cohort Intervention/treatment
Adults with malignant melanoma at high risk of relapse

Adults with malignant melanoma of the following stages:

  • II and III (>/= 1.5 mm Breslow thickness without distant metastases
  • melanoma with lymph node metastases
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

Primary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants in Austria with malignant melanoma at high risk of relapse

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)

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00749684     History of Changes
Other Study ID Numbers: P04083
First Posted: September 9, 2008    Key Record Dates
Results First Posted: March 24, 2011
Last Update Posted: October 19, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs