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

June 20, 2006 updated by: Dermatologic Cooperative Oncology Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44791
        • Recruiting
        • Universitätshautklinik ,St.Josef- Hospital
        • Contact:
          • Norbert Brockmeyer, MD
          • Phone Number: 509-1 0049/234
      • Buxtehude, Germany, 21614
      • Essen, Germany, 45122
        • Recruiting
        • Universitätshautklinik Essen
        • Contact:
          • Carmen Loquai, MD
          • Phone Number: 243 0049/201-723
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinik Eppendorf
        • Contact:
          • Karsten Neuber, MD
          • Phone Number: 2632 0049/42803
      • Hannover, Germany, 30159
        • Recruiting
        • Praxis
        • Contact:
          • Peter von Wussow, MD
          • Phone Number: 3069998 0049/511
      • Heidelberg, Germany, 69115
        • Recruiting
        • Universitätshautklinik Heidelberg
        • Contact:
          • Alexander Enk, MD
      • Homburg/ Saar, Germany, 66421
        • Recruiting
        • Universitätsklinikum des Saarlandes, Hautklinik
        • Contact:
          • Wolfgang Tilgen, MD
          • Phone Number: 3966 0049/6841-162
      • Kiel, Germany, 24105
        • Recruiting
        • Christian- Albrechts- Universität ,Hautklinik
        • Contact:
          • Axel Hauschild, MD
          • Phone Number: 15 0049/431-597
      • Köln, Germany, 50931
        • Recruiting
        • Universitätshautklinik Köln
        • Contact:
          • Cornelia Mauch, MD
          • Phone Number: 537 0049/221478
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätshautklinik Mainz
        • Contact:
          • Kerstin Steinbrink, MD
          • Phone Number: 30 0049/61311771
      • Münster, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster
        • Contact:
          • T. Luger, MD
          • Phone Number: 56501 0049/25183
      • Oldenburg, Germany, 261333
        • Recruiting
        • Städtische Kliniken Oldenburg
        • Contact:
          • Erhard Hölzle, MD
      • Ulm, Germany, 89081
        • Recruiting
        • Universitätshautklinik Ulm
        • Contact:
          • Cord Sunderkötter, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
distant metastasis free survival/(DMFI )

Secondary Outcome Measures

Outcome Measure
overall survival
time to progression
toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermatologic Cooperative Oncology Group

Investigators

  • Principal Investigator: Peter Mohr, MD, Elbeklinikum, Buxtehude, Germany
  • Principal Investigator: Peter von Wussow, MD, 30159 Hannover,Georgstr.46

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 25, 2005

First Submitted That Met QC Criteria

September 25, 2005

First Posted (Estimate)

September 27, 2005

Study Record Updates

Last Update Posted (Estimate)

June 21, 2006

Last Update Submitted That Met QC Criteria

June 20, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-ADJ-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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