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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00723710
First received: July 25, 2008
Last updated: August 19, 2014
Last verified: August 2014

July 25, 2008
August 19, 2014
April 2006
September 2012   (final data collection date for primary outcome measure)
Number of Participants Who Completed Treatment [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Treatment completion was defined as those who completed both the induction and maintenance phases.
Treatment compliance [ Time Frame: Assessed during the 1-year treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00723710 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Approximately 300 patients with malignant melanoma who are free of disease but at high risk for systemic recurrence. The study is conducted in Canada.

Melanoma
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 million international units per square meter (MIU/m^2). 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/m^2. 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
Intron A
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)
Levesque N, Mitchinson K, Lawrie D, Fedorak L, Macdonald D, Normand C, Pouliot JF. Health management program: factors influencing completion of therapy with high-dose interferon alfa-2b for high-risk melanoma. Curr Oncol. 2008 Jan;15(1):36-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00723710
P04600
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

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