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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Dermatologic Cooperative Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dermatologic Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00226408
First received: September 25, 2005
Last updated: June 20, 2006
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Adjuvant
Stage III Malignant Melanoma
Interferon Alpha
Therapy
Drug: Interferon-alpha-2b
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Dermatologic Cooperative Oncology Group:

Primary Outcome Measures:
  • distant metastasis free survival/(DMFI )

Secondary Outcome Measures:
  • overall survival
  • time to progression
  • toxicity

Estimated Enrollment: 600
Study Start Date: November 2003
Estimated Study Completion Date: September 2005
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226408

Contacts
Contact: Peter Mohr, MD 0049 41261 703 ext 6207 p.mohr@elbekliniken.de
Contact: Michael Weichenthal, MD 0049 431 597 ext 1537 mweichenthal@dermatology.uni-kiel.de

Locations
Germany
Universitätshautklinik ,St.Josef- Hospital Recruiting
Bochum, Germany, 44791
Contact: Norbert Brockmeyer, MD    0049/234 ext 509-1      
Elbekliniken Buxtehude Recruiting
Buxtehude, Germany, 21614
Contact: Peter Miohr, MD    0049 4161 703 ext 6207    p.mohr@elbekliniken.de   
Contact: michael weichenthal, MD    0049 431 597 ext 1537    mweichenthal@dermatolgy.uni-kiel.de   
Universitätshautklinik Essen Recruiting
Essen, Germany, 45122
Contact: Carmen Loquai, MD    0049/201-723 ext 243      
Universitätsklinik Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Karsten Neuber, MD    0049/42803 ext 2632      
Praxis Recruiting
Hannover, Germany, 30159
Contact: Peter von Wussow, MD    0049/511 ext 3069998      
Universitätshautklinik Heidelberg Recruiting
Heidelberg, Germany, 69115
Contact: Alexander Enk, MD         
Universitätsklinikum des Saarlandes, Hautklinik Recruiting
Homburg/ Saar, Germany, 66421
Contact: Wolfgang Tilgen, MD    0049/6841-162 ext 3966      
Christian- Albrechts- Universität ,Hautklinik Recruiting
Kiel, Germany, 24105
Contact: Axel Hauschild, MD    0049/431-597 ext 15      
Universitätshautklinik Köln Recruiting
Köln, Germany, 50931
Contact: Cornelia Mauch, MD    0049/221478 ext 537      
Universitätshautklinik Mainz Recruiting
Mainz, Germany, 55131
Contact: Kerstin Steinbrink, MD    0049/61311771 ext 30      
universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: T. Luger, MD    0049/25183 ext 56501      
Städtische Kliniken Oldenburg Recruiting
Oldenburg, Germany, 261333
Contact: Erhard Hölzle, MD         
Universitätshautklinik Ulm Recruiting
Ulm, Germany, 89081
Contact: Cord Sunderkötter, MD         
Sponsors and Collaborators
Dermatologic Cooperative Oncology Group
Investigators
Principal Investigator: Peter Mohr, MD Elbeklinikum, Buxtehude, Germany
Principal Investigator: Peter von Wussow, MD 30159 Hannover,Georgstr.46
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00226408     History of Changes
Other Study ID Numbers: MM-ADJ-5
Study First Received: September 25, 2005
Last Updated: June 20, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dermatologic Cooperative Oncology Group:
melanoma,adjuvant therapy,stageIII Interferon
high dose

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014