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
  Purpose

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 Intervention
Melanoma
Biological: Interferon α-2b

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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


Enrollment: 138
Study Start Date: September 1996
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00749684     History of Changes
Other Study ID Numbers: P04083
Study First Received: September 8, 2008
Results First Received: October 22, 2010
Last Updated: April 28, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Merck Sharp & Dohme Corp.:
interferon-alpha

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

ClinicalTrials.gov processed this record on July 31, 2014