Trial document

This study has been imported from without additional data checks.
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Trial Description

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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)

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

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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Brief Summary in Scientific Language


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Organizational Data

  •   DRKS00000950
  •   2012/10/04
  •   2005/09/12
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT00204529  (
  •   ML17840  (University Hospital Tuebingen)
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Health Condition or Problem studied

  •   Melanoma
  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   Drug: pegylated interferon-alpha-2a
  •   Drug: interferon-alpha-2a
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  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Time to distant metastasis

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Secondary Outcome

- Disease free survival at 5 years
- Overall survival at 5 years
- Quality of life
- Tolerability

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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  •   [---]*
  •   2004/10/31
  •   880
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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

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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

- 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

- 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)

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  • start of 1:1-Block address primary-sponsor
    • University Hospital Tuebingen
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    • Dermatologic Cooperative Oncology Group
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    •   [---]*
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    • Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany
    • Claus Garbe, MD 
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    • Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany
    • Claus Garbe, MD 
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    •   [---]*
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Sources of Monetary or Material Support

  • [---]*
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  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.