Melanoma
Conditions
Keywords
malignant melanoma, adjuvant therapy, Adjuvants, Immunologic
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.
Interventions
DRUGinterferon-alpha-2a
Sponsors
Dermatologic Cooperative Oncology Group
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Germany
Outcome results
None listed