Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon

Therapy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00226408
• Other study ID #: MM-ADJ-5
• Status: Recruiting
• Phase: Phase 3
• First received: September 25, 2005
• Last updated: June 20, 2006
• Start date: November 2003
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: Dermatologic Cooperative Oncology Group
• Contact: Peter Mohr, MD
• Phone: 0049 41261 703
• Email: p.mohr[@]elbekliniken.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adjuvant
• Interferon Alpha
• Melanoma
• Stage III Malignant Melanoma
• Therapy

Intervention

Drug:
• Interferon-alpha-2b

Locations

Country	Name	City	State
Germany	Universitätshautklinik ,St.Josef- Hospital	Bochum
Germany	Elbekliniken Buxtehude	Buxtehude
Germany	Universitätshautklinik Essen	Essen
Germany	Universitätsklinik Eppendorf	Hamburg
Germany	Praxis	Hannover
Germany	Universitätshautklinik Heidelberg	Heidelberg
Germany	Universitätsklinikum des Saarlandes, Hautklinik	Homburg/ Saar
Germany	Christian- Albrechts- Universität ,Hautklinik	Kiel
Germany	Universitätshautklinik Köln	Köln
Germany	Universitätshautklinik Mainz	Mainz
Germany	universitätsklinikum Münster	Münster
Germany	Städtische Kliniken Oldenburg	Oldenburg
Germany	Universitätshautklinik Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Dermatologic Cooperative Oncology Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	distant metastasis free survival/(DMFI )
Secondary	overall survival
Secondary	time to progression
Secondary	toxicity

External Links

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