Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600 AM2)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00723710

First received: July 25, 2008

Last updated: December 11, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 25, 2008
Last Updated Date	December 11, 2012
Start Date ^ICMJE	April 2006
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 25, 2008)	Treatment compliance [ Time Frame: Assessed during the 1-year treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00723710 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600 AM2)
Official Title ^ICMJE	Guidelines to the Intron A® Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy
Brief Summary	Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Approximately 250 patients with malignant melanoma who are free of disease but at high risk for systemic recurrence. The study is conducted in Canada.
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	Biological: Intron A (interferon alfa-2b; SCH 30500) The recommended regimen includes an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m2. The induction treatment should be followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m2. Therapy should be administered for a total of one year unless the disease progresses or the treatment has lead to recurrent unmanageable serious adverse effects. Other Name: SCH 30500
Study Group/Cohort (s)	Arm 1 Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence. Intervention: Biological: Intron A (interferon alfa-2b; SCH 30500)
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	300
Completion Date	September 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Signed informed consent Age > 18 years Confirmed melanoma Patient has been prescribed Intron A therapy for High-Risk Stage II & III Melanoma Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval) Proper contraception in both male and female subjects and the female partner(s) of male study subjects Exclusion Criteria: Metastatic disease at the time of diagnosis Other malignancies History of non compliance to other therapies Pregnancy or breast feeding Previous Intron A therapy
Gender	Both
Ages	18 Years and older
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	NCT00723710
Other Study ID Numbers ^ICMJE	P04600
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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