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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00723710
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : October 28, 2013
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Melanoma Biological: Intron A (interferon alfa-2b; SCH 30500)

Study Type : Observational
Actual Enrollment : 299 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : April 2006
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
Intron A
Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence.
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

Primary Outcome Measures :
  1. Number of Participants Who Completed Treatment [ Time Frame: Up to 1 year ]
    Treatment completion was defined as those who completed both the induction and maintenance phases.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately 300 patients with malignant melanoma who are free of disease but at high risk for systemic recurrence. The study is conducted in Canada.

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00723710     History of Changes
Other Study ID Numbers: P04600
First Posted: July 29, 2008    Key Record Dates
Results First Posted: October 28, 2013
Last Update Posted: August 26, 2015
Last Verified: August 2015

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