MelanomaNCT00749684
Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)
An observational study of Melanoma, run by Merck Sharp & Dohme LLC.
Trial summary
The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Interferon α-2b
- Type of treatment
- Injection or infusion
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Dec 1996to Sep 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants in Austria with malignant melanoma at high risk of relapse
Who may be able to join
- Male and female participants
- Age 18-70 years
- Malignant melanoma stage II or III (>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
- An excision border of at least 2 cm around the primary tumor
- Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
- ECOG status 0-1 (= Karnofsky Index >/= 80)
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- Laboratory parameters
- Hematocrit >= 33%
- Leukocytes >= 3000/μl
- Thrombocytes >= 100000/μl
- Alanine aminotransferase(ALT) <= 2x normal values
- Bilirubin <= 2x normal values
Who cannot join
- Known allergy to one of the medications or any of its component parts
- Refusal on the part of participants capable of childbearing to use a reliable contraceptive
- Lactating mothers
- Presence of distant metastases
- Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is > 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
- Participants on corticosteroid treatment or treatment with an immunomodulating substance
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- Preexisting psychiatric illness, particularly serious depression
- Prior adjuvant radio-, chemo-, or immuno-therapy
- Treatment with an investigational drug within the prior 30 days
- Participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration
- Myocardial infarction within the prior year
- An unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study
- Psoriasis (a relative exclusion criterion, since interferon can aggravate psoriasis; decision to be based on risk/benefit analysis)
About this study
Official title: Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.
The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control).
Read the detailed description
Observational study to evaluate the tolerability and efficacy (vs historical controls) of a high-dose therapy scheme with interferon-α-2b (IntronA®):
Adjuvant treatment with interferon-α-2 has been demonstrated in a number of studies to have an antiproliferative effect on malignant melanoma. In these cases a response rate of up to 20% could be achieved with a dose of 10 million IU or more 3x/week or daily. Kirkwood et al. showed in a study carried out in ECOG (the Eastern Cooperative Oncology Group, study no. 1684) that there was a clear and significant survival advantage versus the observation group with the following dose:
20 mio IU/m² interferon-α-2b (IntronA®) 5x/week iv over the course of one month followed by 11 months with 10 mio IU/m² 3x/week sc.
- Conditions
- Melanoma
- Being tested
- Interferon α-2b
- Keywords
- interferon-alpha
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon α-2bBiological
Also called Intron A
20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months.
| Study group | Role | What they receive |
|---|---|---|
| Adults with malignant melanoma at high risk of relapse | Adults with malignant melanoma of the following stages:
* II and III (>/= 1.5 mm Breslow thickness without distant metastases
* melanoma with lymph node metastases Receives: Biological: Interferon α-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Disease Recurrence
Number of participants with disease recurrence was being measured.
Measured: Throughout 12 months of treatment and 24 months of follow-up
Relapse Free Survival Time
Median time to recurrence according to Kaplan Maier evaluation
Measured: Throughout 12 months of treatment and 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startDec 1996
- Primary completionSep 2009
- Study completionSep 2009
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 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
- NCT00749684
- Sponsor's protocol ID
- P04083
- Status last verified
- Oct 2015
- First submitted
- 8 Sep 2008
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.
- ClinicalTrials.gov ID
- NCT00749684
- Acronym / sponsor ID
- P04083
- Conditions
- Melanoma
- Keywords
- interferon-alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 1996
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 24 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control).
Detailed description
Observational study to evaluate the tolerability and efficacy (vs historical controls) of a high-dose therapy scheme with interferon-α-2b (IntronA®):
Adjuvant treatment with interferon-α-2 has been demonstrated in a number of studies to have an antiproliferative effect on malignant melanoma. In these cases a response rate of up to 20% could be achieved with a dose of 10 million IU or more 3x/week or daily. Kirkwood et al. showed in a study carried out in ECOG (the Eastern Cooperative Oncology Group, study no. 1684) that there was a clear and significant survival advantage versus the observation group with the following dose:
20 mio IU/m² interferon-α-2b (IntronA®) 5x/week iv over the course of one month followed by 11 months with 10 mio IU/m² 3x/week sc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with malignant melanoma at high risk of relapse | – | Biological: Interferon α-2bAdults with malignant melanoma of the following stages: * II and III (>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants in Austria with malignant melanoma at high risk of relapse
Key inclusion criteria (12 listed)
- Male and female participants
- Age 18-70 years
- Malignant melanoma stage II or III (>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
- An excision border of at least 2 cm around the primary tumor
- Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
Key exclusion criteria (13 listed)
- Known allergy to one of the medications or any of its component parts
- Refusal on the part of participants capable of childbearing to use a reliable contraceptive
- Lactating mothers
- Presence of distant metastases
- Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is > 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
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 |
|---|---|---|
| Interferon α-2bAlso: Intron A20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months. | Biological | Adults with malignant melanoma at high risk of relapse |
Primary outcome
Number of Participants With Disease Recurrence
Time frame: Throughout 12 months of treatment and 24 months of follow-up
Number of participants with disease recurrence was being measured.
Relapse Free Survival Time
Time frame: Throughout 12 months of treatment and 24 months of follow-up
Median time to recurrence according to Kaplan Maier evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 12 inclusion and 13 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 19 Oct 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 24 Mar 2011). 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 With Disease Recurrence (time frame: Throughout 12 months of treatment and 24 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2015.