Standard High-Dose Alpha Interferon Versus Intermittent H... | NCT00226408

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Sep 25, 2005

First Submission Date that Met QC Criteria

Sep 25, 2005

First Posted Date

Sep 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2006

Last Update Posted Date

Jun 21, 2006Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600

Name	Type	Description	Arm Group Labels	Other Names
Interferon-alpha-2b	Drug

Measure	Description	Time Frame
distant metastasis free survival/(DMFI )

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Mohr, MD	Contact	0049 41261 703	6207	p.mohr@elbekliniken.de
Michael Weichenthal, MD	Contact	0049 431 597	1537	mweichenthal@dermatology.uni-kiel.de

Overall Officials

Name	Affiliation	Role
Peter Mohr, MD	Elbeklinikum, Buxtehude, Germany	Principal Investigator
Peter von Wussow, MD	30159 Hannover,Georgstr.46	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätshautklinik ,St.Josef- Hospital	Recruiting	Bochum		44791	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26503196	Derived	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.

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D021901	DNA, Intergenic
D040481	Genome Components
D016678	Genome
D040342	Genetic Structures
D055614	Genetic Phenomena
D040461	Gene Components
D005796	Genes