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

August 24, 2015 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • SCH 30500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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