Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00000950

Trial Description

start of 1:1-Block title

Title

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)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000950
  •   2012/10/04
  •   2005/09/12
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00204529  (ClinicalTrials.gov)
  •   ML17840  (University Hospital Tuebingen)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Melanoma
  •   C43 -  Malignant melanoma of skin
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: pegylated interferon-alpha-2a
  •   Drug: interferon-alpha-2a
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Time to distant metastasis

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2004/10/31
  •   880
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University Hospital Tuebingen
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Dermatologic Cooperative Oncology Group
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany
    • Claus Garbe, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany
    • Claus Garbe, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • [---]*
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov 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.