MelanomaPhase 3NCT00204529
Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB
A Phase 3 study testing pegylated interferon-alpha-2a and interferon-alpha-2a in people with Melanoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- pegylated interferon-alpha-2a and interferon-alpha-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cutaneous melanoma
- ≥ 18 years of age and < 75 years of age
- Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymph node staging either per sentinel node biopsy or elective lymph node dissection)
- Have a Karnofsky performance status of ≥ 80%
- Negative pregnancy test
- Start of therapy within three months after surgery
- Informed consent
Who cannot join
- Pregnant or lactating women
- Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
- Mucous membrane or ocular melanoma
- Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening)
- Patients who have received chemotherapy or vaccines for melanoma
- Patients with tumor progression under a previous adjuvant interferon therapy or within three months after termination of interferon therapy (patients previously receiving adjuvant interferon therapy in another tumor stage without disease progression may be included)
Show all 24Show fewer
- History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
- ALAT or ASAT > 2 x ULN
- Bilirubin > 2 x ULN
- Creatinine > 2 x ULN
- Patients who have a history of depression or other psychiatric diseases requiring hospitalisation
- Patients with seizure disorders requiring anticonvulsant therapy
- Any of the following abnormal baseline hematologic/laboratory values:
- Hb <10g/dl
- WBC <3.0 x 109 /l
- Platelets <100x109/l
- Neutrophils < 1.5 x 109/l
- History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes)
- Unwilling or unable to comply with the requirements of the protocol for the duration of the study
- Known infection with HBV, HCV, HIV
- Evidence of allergy or hypersensitivity against IFN or pegylated interferon
- Thyroid disease poorly controlled on prescribed medications
- Systemic corticosteroid therapy for any reason (>1 month)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-alpha-2 (PEG-IFN) to 'Low-dose' Interferon-alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002)
The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.
A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.
- Conditions
- Melanoma
- Being tested
- pegylated interferon-alpha-2a, interferon-alpha-2a
- Keywords
- malignant melanoma, adjuvant therapy, Adjuvants, Immunologic
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated interferon-alpha-2aDrug
interferon-alpha-2aDrug
| Study group | Role | What they receive |
|---|---|---|
| PegIFN | Experimental | pegylated interferon-alpha-2a Receives: Drug: pegylated interferon-alpha-2a |
| IFN | Active comparator | interferon-alpha-2a Receives: Drug: interferon-alpha-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to distant metastasis
Measured: From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (4)
Disease free survival
Measured: 5 years
Overall survival
Measured: 5 years
Quality of life
Measured: Measured at different visits (week 0, week 12, month 3, month 6)
Number and Grade of Adverse Events
Measured: Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatologic Cooperative Oncology Group
- Responsible party
- Principal investigator, Thomas Eigentler, University Hospital Tuebingen
- Investigators
- Claus Garbe, MD, Principal investigator, Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, GermanyHubert Pehamberger, MD, Principal investigator, Department of Dermatology, University Hospital Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204529
- Sponsor's protocol ID
- ML17840
- Status last verified
- May 2017
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2017
- Results posted
- No
Publications
Eigentler TK, Gutzmer R, Hauschild A, Heinzerling L, Schadendorf D, Nashan D, Holzle E, Kiecker F, Becker J, Sunderkotter C, Moll I, Richtig E, Ponitzsch I, Pehamberger H, Kaufmann R, Pfohler C, Vogt T, Berking C, Praxmarer M, Garbe C; Dermatologic Cooperative Oncology Group (DeCOG). Adjuvant treatment with pegylated interferon alpha-2a versus low-dose interferon alpha-2a in patients with high-risk melanoma: a randomized phase III DeCOG trial. Ann Oncol. 2016 Aug;27(8):1625-32. doi: 10.1093/annonc/mdw225. Epub 2016 Jun 10.
PubMed 27287206
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-alpha-2 (PEG-IFN) to 'Low-dose' Interferon-alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002)
- ClinicalTrials.gov ID
- NCT00204529
- Acronym / sponsor ID
- ML17840
- Conditions
- Melanoma
- Keywords
- malignant melanoma, adjuvant therapy, Adjuvants, Immunologic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Dermatologic Cooperative Oncology Group
- Study start
- Oct 2004 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.
A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PegIFN | Experimental | Drug: pegylated interferon-alpha-2apegylated interferon-alpha-2a |
| IFN | Active comparator | Drug: interferon-alpha-2ainterferon-alpha-2a |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven cutaneous melanoma
- ≥ 18 years of age and < 75 years of age
- Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymph node staging either per sentinel node biopsy or elective lymph node dissection)
- Have a Karnofsky performance status of ≥ 80%
- Negative pregnancy test
Key exclusion criteria (24 listed)
- Pregnant or lactating women
- Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
- Mucous membrane or ocular melanoma
- Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening)
- Patients who have received chemotherapy or vaccines for melanoma
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 |
|---|---|---|
| pegylated interferon-alpha-2a | Drug | PegIFN |
| interferon-alpha-2a | Drug | IFN |
Primary outcome
Time to distant metastasis
Time frame: From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months
4 secondary outcomes
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life
Time frame: Measured at different visits (week 0, week 12, month 3, month 6)
Number and Grade of Adverse Events
Time frame: Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 27287206Eigentler TK, Gutzmer R, Hauschild A, Heinzerling L, Schadendorf D, Nashan D, Holzle E, Kiecker F, Becker J, Sunderkotter C, Moll I, Richtig E, Ponitzsch I, Pehamberger H, Kaufmann R, Pfohler C, Vogt T, Berking C, Praxmarer M, Garbe C; Dermatologic Cooperative Oncology Group (DeCOG). Adjuvant treatment with pegylated interferon alpha-2a versus low-dose interferon alpha-2a in patients with high-risk melanoma: a randomized phase III DeCOG trial. Ann Oncol. 2016 Aug;27(8):1625-32. doi: 10.1093/annonc/mdw225. Epub 2016 Jun 10.
- Synopsis of study protocolLink provided by the sponsor.
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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.
Claus Garbe, MD principal investigator
Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany
Hubert Pehamberger, MD principal investigator
Department of Dermatology, University Hospital Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pegylated interferon-alpha-2a and interferon-alpha-2a in people with Melanoma, run by University Hospital Tuebingen at 1 site in Germany.
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 7 inclusion and 24 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to distant metastasis (time frame: From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months). 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 NCT00204529, 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 3 May 2017.