Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB
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)
1 other identifier
interventional
901
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
Longer than P75 for phase_3
1 active site
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
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 3, 2017
May 1, 2017
8.6 years
September 12, 2005
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to distant metastasis
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
5 years
Overall survival
5 years
Quality of life
Measured at different visits (week 0, week 12, month 3, month 6)
Number and Grade of Adverse Events
Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy)
Study Arms (2)
PegIFN
EXPERIMENTALpegylated interferon-alpha-2a
IFN
ACTIVE COMPARATORinterferon-alpha-2a
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Related Publications (1)
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.
PMID: 27287206DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus Garbe, MD
Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany
- PRINCIPAL INVESTIGATOR
Hubert Pehamberger, MD
Department of Dermatology, University Hospital Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
October 1, 2004
Primary Completion
May 1, 2013
Study Completion
December 1, 2016
Last Updated
May 3, 2017
Record last verified: 2017-05