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

October 16, 2015 updated by: Merck Sharp & Dohme LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Intron A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout 12 months of treatment and 24 months of follow-up
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
Throughout 12 months of treatment and 24 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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