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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723710
• Other study ID #: P04600
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: August 24, 2015
• Start date: April 2006
• Est. completion date: September 2012

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Completed Treatment	Treatment completion was defined as those who completed both the induction and maintenance phases.	Up to 1 year	No