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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)


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Melanoma

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Trial Information

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)


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to distant metastasis

Principal Investigator

Claus Garbe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ML17840

NCT ID:

NCT00204529

Start Date:

October 2004

Completion Date:

December 2015

Related Keywords:

  • Melanoma
  • malignant melanoma
  • adjuvant therapy
  • Adjuvants, Immunologic
  • Melanoma

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