NCT00226408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

June 21, 2006

Status Verified

September 1, 2005

First QC Date

September 25, 2005

Last Update Submit

June 20, 2006

Conditions

AdjuvantStage III Malignant MelanomaInterferon AlphaTherapy

Keywords

melanoma,adjuvant therapy,stageIII Interferonhigh dose

Outcome Measures

Primary Outcomes (1)

  • distant metastasis free survival/(DMFI )

Secondary Outcomes (3)

  • overall survival

  • time to progression

  • toxicity

Interventions

Interferon-alpha-2bDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Universitätshautklinik ,St.Josef- Hospital

Bochum, 44791, Germany

RECRUITING

Elbekliniken Buxtehude

Buxtehude, 21614, Germany

RECRUITING

Universitätshautklinik Köln

Cologne, 50931, Germany

RECRUITING

Universitätshautklinik Essen

Essen, 45122, Germany

RECRUITING

Universitätsklinik Eppendorf

Hamburg, 20246, Germany

RECRUITING

Praxis

Hanover, 30159, Germany

RECRUITING

Universitätshautklinik Heidelberg

Heidelberg, 69115, Germany

RECRUITING

Universitätsklinikum des Saarlandes, Hautklinik

Homburg/ Saar, 66421, Germany

RECRUITING

Christian- Albrechts- Universität ,Hautklinik

Kiel, 24105, Germany

RECRUITING

Universitätshautklinik Mainz

Mainz, 55131, Germany

RECRUITING

universitätsklinikum Münster

Münster, 48149, Germany

RECRUITING

Städtische Kliniken Oldenburg

Oldenburg, 261333, Germany

RECRUITING

Universitätshautklinik Ulm

Ulm, 89081, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26503196DERIVED

Related Links

MeSH Terms

Conditions

Melanoma

Interventions

Introns

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • Peter Mohr, MD

    Elbeklinikum, Buxtehude, Germany

    PRINCIPAL INVESTIGATOR

  • Peter von Wussow, MD

    30159 Hannover,Georgstr.46

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Mohr, MD

CONTACT

0049 41261 703p.mohr@elbekliniken.de

Michael Weichenthal, MD

CONTACT

0049 431 597mweichenthal@dermatology.uni-kiel.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2005

First Posted

September 27, 2005

Study Start

November 1, 2003

Study Completion

September 1, 2005

Last Updated

June 21, 2006

Record last verified: 2005-09

Locations

DE(13)