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

Sponsor
Dermatologic Cooperative Oncology Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00226408
Collaborator
(none)
600
Enrollment
13
Locations
22
Duration (Months)
46.2
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Nov 1, 2003
Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

  1. distant metastasis free survival/(DMFI ) []

Secondary Outcome Measures

  1. overall survival []

  2. time to progression []

  3. toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Universitätshautklinik ,St.Josef- Hospital Bochum Germany 44791
2 Elbekliniken Buxtehude Buxtehude Germany 21614
3 Universitätshautklinik Essen Essen Germany 45122
4 Universitätsklinik Eppendorf Hamburg Germany 20246
5 Praxis Hannover Germany 30159
6 Universitätshautklinik Heidelberg Heidelberg Germany 69115
7 Universitätsklinikum des Saarlandes, Hautklinik Homburg/ Saar Germany 66421
8 Christian- Albrechts- Universität ,Hautklinik Kiel Germany 24105
9 Universitätshautklinik Köln Köln Germany 50931
10 Universitätshautklinik Mainz Mainz Germany 55131
11 universitätsklinikum Münster Münster Germany 48149
12 Städtische Kliniken Oldenburg Oldenburg Germany 261333
13 Universitätshautklinik Ulm Ulm Germany 89081

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00226408
Other Study ID Numbers:
  • MM-ADJ-5
First Posted:
Sep 27, 2005
Last Update Posted:
Jun 21, 2006
Last Verified:
Sep 1, 2005
Keywords provided by , ,
melanoma,adjuvant therapy,stageIII Interferon
high dose
Additional relevant MeSH terms:
Melanoma
Interferons
Interferon-alpha
Interferon alpha-2

Study Results

No Results Posted as of Jun 21, 2006