Clinical trial NCT00226408: Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon
Official title: Randomized, Multicenter Study for Adjuvant Treatment of Stage III Malignant Melanoma: Intermittent, High-Dose Intravenous Interferon Alpha-2b Versus Standard High-Dose Interferon Alpha-2b Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Adjuvant
Stage III Malignant Melanoma
Interferon Alpha
Therapy
Keywords: melanoma,adjuvant therapy,stageIII Interferon
high dose
Lead sponsor: Dermatologic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 survival (DMFI) as a primary endpoint.

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 repeated 3 times with 12 treatment-free-weeks between the cycles

Secondary endpoints: Improved overall survival rate, Assess side effects of therapy in both treatment arms, Assess time spent on sick leave, Assess number of treatment-related days in hospital, Assess overall performance status, Assess blood MX protein levels

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: distant metastasis free survival/(DMFI )
Secondary outcomes:
measure: overall survival
measure: time to progression
measure: toxicity
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Universitätshautklinik ,St.Josef- Hospital
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude
city: Essen
country: Germany
facility: Universitätshautklinik Essen
city: Hamburg
country: Germany
facility: Universitätsklinik Eppendorf
city: Hannover
country: Germany
facility: Praxis
city: Heidelberg
country: Germany
facility: Universitätshautklinik Heidelberg
city: Homburg/ Saar
country: Germany
facility: Universitätsklinikum des Saarlandes, Hautklinik
city: Kiel
country: Germany
facility: Christian- Albrechts- Universität ,Hautklinik
city: Köln
country: Germany
facility: Universitätshautklinik Köln
city: Mainz
country: Germany
facility: Universitätshautklinik Mainz
city: Münster
country: Germany
facility: universitätsklinikum Münster
city: Oldenburg
country: Germany
facility: Städtische Kliniken Oldenburg
city: Ulm
country: Germany
facility: Universitätshautklinik Ulm
Study officials:
affiliation: Elbeklinikum, Buxtehude, Germany
name: Peter Mohr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 30159 Hannover,Georgstr.46
name: Peter von Wussow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohr P, Hauschild A, Trefzer U, Enk A, Tilgen W, Loquai C, Gogas H, Haalck T, Koller J, Dummer R, Gutzmer R, Brockmeyer N, Holzle E, Sunderkotter C, Mauch C, Stein A, Schneider LA, Podda M, Goppner D, Schadendorf D, Weichenthal M. Intermittent High-Dose Intravenous Interferon Alfa-2b for Adjuvant Treatment of Stage III Melanoma: Final Analysis of a Randomized Phase III Dermatologic Cooperative Oncology Group Trial. J Clin Oncol. 2015 Dec 1;33(34):4077-84. doi: 10.1200/JCO.2014.59.6932. Epub 2015 Oct 26.