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:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00749684

First received: September 8, 2008

Last updated: February 25, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2008
Last Updated Date	February 25, 2011
Start Date ^ICMJE	September 1996
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 25, 2011)	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
Original Primary Outcome Measures ^ICMJE (submitted: September 8, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00749684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: September 8, 2008)	Frequency and severity of adverse events [ Time Frame: Throughout 12 months of treatment and 24 months of follow-up ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083AM1)(COMPLETED)
Official Title ^ICMJE	Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adult participants in Austria with malignant melanoma at high risk of relapse
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	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
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	138
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00749684
Other Study ID Numbers ^ICMJE	P04083
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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