MelanomaNCT00723710
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
An observational study of Melanoma, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Intron A (interferon alfa-2b; SCH 30500)
- Type of treatment
- Injection or infusion
- How many people
- 299 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Metastatic disease at the time of diagnosis
- Other malignancies
- History of non compliance to other therapies
- Pregnancy or breast feeding
- Previous Intron A therapy
About this study
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
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.
- Conditions
- Melanoma
- Being tested
- Intron A (interferon alfa-2b; SCH 30500)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intron A (interferon alfa-2b; SCH 30500)Biological
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Intron A | Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence. Receives: Biological: Intron A (interferon alfa-2b; SCH 30500) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed Treatment
Treatment completion was defined as those who completed both the induction and maintenance phases.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723710
- Sponsor's protocol ID
- P04600
- Status last verified
- Aug 2015
- First submitted
- 25 Jul 2008
- Last updated
- 26 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18317583
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00723710
- Acronym / sponsor ID
- P04600
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 28 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intron A | – | Biological: Intron A (interferon alfa-2b; SCH 30500)Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- Metastatic disease at the time of diagnosis
- Other malignancies
- History of non compliance to other therapies
- Pregnancy or breast feeding
- Previous Intron A therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intron A (interferon alfa-2b; SCH 30500)Also: SCH 30500The 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. | Biological | Intron A |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18317583Levesque 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed Treatment (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.