Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

University Hospital Tuebingen

Status and phase

Completed

Phase 3

Conditions

Melanoma

Treatments

Drug: interferon-alpha-2a

Drug: pegylated interferon-alpha-2a

Study type

Interventional

Funder types

Other

Identifiers

NCT00204529

ML17840

Details and patient eligibility

About

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.

Enrollment

901 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)