Status:
COMPLETED
Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Dermatologic Cooperative Oncology Group
Conditions:
Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 st...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
901 Patients enrolled
Trial Details
Trial ID
NCT00204529
Start Date
October 1 2004
End Date
December 1 2016
Last Update
May 3 2017
Active Locations (1)
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1
Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076