Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00749684
First received: September 8, 2008
Last updated: April 28, 2014
Last verified: April 2014

September 8, 2008
April 28, 2014
September 1996
September 2009   (final data collection date for primary outcome measure)
  • Number of Participants With Disease Recurrence [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Median time to recurrence according to Kaplan Maier evaluation
  • Tolerability of treatment [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: No ]
  • Survival time [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: No ]
  • Relapse-free interval (from the start of interferon treatment until the appearance of locoregional recurrence and/or distant metastases) [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: No ]
  • All adverse events, regardless of causality [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: Yes ]
  • Quality of life as measured by a validated questionnaire [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00749684 on ClinicalTrials.gov Archive Site
Not Provided
Frequency and severity of adverse events [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083AM1)(COMPLETED)
Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adult participants in Austria with malignant melanoma at high risk of relapse

Melanoma
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
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
Intervention: Biological: Interferon α-2b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
September 2009
September 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00749684
P04083
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP