Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600 AM2)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma
Intervention: Intron A (interferon alfa-2b; SCH 30500) (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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.
Clinical Details
Official title: Guidelines to the Intron AŽ Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Treatment compliance
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Coordinating Location, Pointe-Claire, Canada; Recruiting
Additional Information
Starting date: April 2006
Last updated: November 30, 2011
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