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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

901 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PegIFN

pegylated interferon-alpha-2a

Group Type EXPERIMENTAL

pegylated interferon-alpha-2a

Intervention Type DRUG

IFN

interferon-alpha-2a

Group Type ACTIVE_COMPARATOR

interferon-alpha-2a

Intervention Type DRUG

Interventions

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pegylated interferon-alpha-2a

Intervention Type DRUG

interferon-alpha-2a

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No