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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Treatment Active 18 and over Pharmaceutical / Industry P04600
NCT00723710

Trial Description

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Schering-Plough Research Institute

SP Clinical Trial Registry Call Center

Ph: 1-888-772-8734

Trial Sites

Canada

Pointe-Claire

Coordinating Location

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00723710
Information obtained from ClinicalTrials.gov on May 07, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.