Status:
UNKNOWN
Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon
Lead Sponsor:
Dermatologic Cooperative Oncology Group
Conditions:
Adjuvant
Stage III Malignant Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free surviva...
Detailed Description
Arm A: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v followed by 48 weeks of treatment with 3 x 10 MIU/m2 s.c Arm B: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v repeate...
Eligibility Criteria
Inclusion
- Histological documentet cutaneous malognant melanoma
- Stage IIIa, IIIb, IIIc (AJCC 2002)
- R0 resection dating back no longer than 56 days
- Performance status (ECOG o-1)
- Bone marrow funktion: White cell count \> 3000 cells/ul, platletts \> 100000 cells/ul, hemoglobin \> 10 g/dl
- Liver and kidney funktion: Serum creatinin \< 1.5 times upper limit of normal, AST and ALT \< 2.5 times upper limit of normal, Serum bilirubin \< 2 times upper limit of normal
- Written inform consent
Exclusion
- Confirmed distant metastasis
- Choroid or mucosal melanoma
- Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception
- Active autoimmun disease
- patients with history of neuropsychiatric disease requiring hospitalization
- Severe medical condition such us:
- Florid hepatitis
- Severe acute infection
- Myocardial infarction within the past year,symptomatic angina pectoris
- Grade III to IV congestive heart failure
- serious pulmonary disease
- HIV-positive patients with an AIDS - defining condition
- treatment in another clinical drug trial within the last 30 days
- A history of hypersensitivity to interferon alfa
- History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)
- Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00226408
Start Date
November 1 2003
End Date
September 1 2005
Last Update
June 21 2006
Active Locations (13)
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1
Universitätshautklinik ,St.Josef- Hospital
Bochum, Germany, 44791
2
Elbekliniken Buxtehude
Buxtehude, Germany, 21614
3
Universitätshautklinik Köln
Cologne, Germany, 50931
4
Universitätshautklinik Essen
Essen, Germany, 45122