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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723710

Purpose

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	Intervention
Melanoma	Biological: Intron A (interferon alfa-2b; SCH 30500)

MedlinePlus related topics: Melanoma

Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Treatment compliance [ Time Frame: Assessed during the 1-year treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1 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 MIU/m2. 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/m2. 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.

Groups/Cohorts

Assigned Interventions

Arm 1

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 MIU/m2. 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/m2. 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Approximately 250 patients with malignant melanoma who are free of disease but at high risk for systemic recurrence. The study is conducted in Canada.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723710

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Canada
Coordinating Location	Recruiting
Pointe-Claire, Canada

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04600
Study First Received:	July 25, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00723710
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Interferon-alpha
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Interferons
Neuroepithelioma

Nevus
Interferon Alfa-2a
Interferon Alfa-2b
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antiviral Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009