NCT00723710

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 28, 2013

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

6.4 years

First QC Date

July 25, 2008

Results QC Date

August 21, 2013

Last Update Submit

August 24, 2015

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Completed Treatment

    Treatment completion was defined as those who completed both the induction and maintenance phases.

    Up to 1 year

Study Arms (1)

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)

Interventions

Intron A (interferon alfa-2b; SCH 30500)BIOLOGICAL

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.

Also known as: SCH 30500
Intron A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Metastatic disease at the time of diagnosis
  • Other malignancies
  • History of non compliance to other therapies
  • Pregnancy or breast feeding
  • Previous Intron A therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.3747/co.2008.200.

    PMID: 18317583RESULT

MeSH Terms

Conditions

Melanoma

Interventions

IntronsInterferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenesInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

April 1, 2006

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 26, 2015

Results First Posted

October 28, 2013

Record last verified: 2015-08