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

Primary Purpose

Adjuvant, Stage III Malignant Melanoma, Interferon Alpha

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Interferon-alpha-2b
Sponsored by
Dermatologic Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjuvant focused on measuring melanoma,adjuvant therapy,stageIII Interferon, high dose

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätshautklinik ,St.Josef- HospitalRecruiting
  • Elbekliniken BuxtehudeRecruiting
  • Universitätshautklinik EssenRecruiting
  • Universitätsklinik EppendorfRecruiting
  • PraxisRecruiting
  • Universitätshautklinik HeidelbergRecruiting
  • Universitätsklinikum des Saarlandes, HautklinikRecruiting
  • Christian- Albrechts- Universität ,HautklinikRecruiting
  • Universitätshautklinik KölnRecruiting
  • Universitätshautklinik MainzRecruiting
  • universitätsklinikum MünsterRecruiting
  • Städtische Kliniken OldenburgRecruiting
  • Universitätshautklinik UlmRecruiting

Outcomes

Primary Outcome Measures

distant metastasis free survival/(DMFI )

Secondary Outcome Measures

overall survival
time to progression
toxicity

Full Information

First Posted
September 25, 2005
Last Updated
June 20, 2006
Sponsor
Dermatologic Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00226408
Brief Title
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

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dermatologic Cooperative Oncology Group

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjuvant, Stage III Malignant Melanoma, Interferon Alpha, Therapy
Keywords
melanoma,adjuvant therapy,stageIII Interferon, high dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon-alpha-2b
Primary Outcome Measure Information:
Title
distant metastasis free survival/(DMFI )
Secondary Outcome Measure Information:
Title
overall survival
Title
time to progression
Title
toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Mohr, MD
Phone
0049 41261 703
Ext
6207
Email
p.mohr@elbekliniken.de
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Weichenthal, MD
Phone
0049 431 597
Ext
1537
Email
mweichenthal@dermatology.uni-kiel.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mohr, MD
Organizational Affiliation
Elbeklinikum, Buxtehude, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter von Wussow, MD
Organizational Affiliation
30159 Hannover,Georgstr.46
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätshautklinik ,St.Josef- Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Brockmeyer, MD
Phone
0049/234
Ext
509-1
Facility Name
Elbekliniken Buxtehude
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Miohr, MD
Phone
0049 4161 703
Ext
6207
Email
p.mohr@elbekliniken.de
First Name & Middle Initial & Last Name & Degree
michael weichenthal, MD
Phone
0049 431 597
Ext
1537
Email
mweichenthal@dermatolgy.uni-kiel.de
Facility Name
Universitätshautklinik Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Loquai, MD
Phone
0049/201-723
Ext
243
Facility Name
Universitätsklinik Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Neuber, MD
Phone
0049/42803
Ext
2632
Facility Name
Praxis
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter von Wussow, MD
Phone
0049/511
Ext
3069998
Facility Name
Universitätshautklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Enk, MD
Facility Name
Universitätsklinikum des Saarlandes, Hautklinik
City
Homburg/ Saar
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Tilgen, MD
Phone
0049/6841-162
Ext
3966
Facility Name
Christian- Albrechts- Universität ,Hautklinik
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Hauschild, MD
Phone
0049/431-597
Ext
15
Facility Name
Universitätshautklinik Köln
City
Köln
ZIP/Postal Code
50931
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornelia Mauch, MD
Phone
0049/221478
Ext
537
Facility Name
Universitätshautklinik Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Steinbrink, MD
Phone
0049/61311771
Ext
30
Facility Name
universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T. Luger, MD
Phone
0049/25183
Ext
56501
Facility Name
Städtische Kliniken Oldenburg
City
Oldenburg
ZIP/Postal Code
261333
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erhard Hölzle, MD
Facility Name
Universitätshautklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cord Sunderkötter, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26503196
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.
Results Reference
derived
Links:
URL
http://www.ADO-homepage.de
Description
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Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon

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