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Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

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

NCT00226408•Dermatologic Cooperative Oncology Group

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 70 years

Sex

ALL

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
+6 more criteria

Locations (13)

Universitätshautklinik ,St.Josef- Hospital

Bochum, Germany

Elbekliniken Buxtehude

Buxtehude, Germany

Universitätshautklinik Köln

Cologne, Germany

Universitätshautklinik Essen

Essen, Germany

Universitätsklinik Eppendorf

Hamburg, Germany

Praxis

Hanover, Germany

Universitätshautklinik Heidelberg

Heidelberg, Germany

Universitätsklinikum des Saarlandes, Hautklinik

Homburg/ Saar, Germany

Christian- Albrechts- Universität ,Hautklinik

Kiel, Germany

Universitätshautklinik Mainz

Mainz, Germany

Key Dates

Start Date

November 1, 2003

Completion Date

September 1, 2005

Last Updated

June 21, 2006

Enrollment

600

Estimated participants

Conditions

AdjuvantStage III Malignant MelanomaInterferon AlphaTherapy

Interventions

Interferon-alpha-2b

DRUG

Contacts

Peter Mohr, MD

CONTACT

0049 41261 703 p.mohr@elbekliniken.de

Michael Weichenthal, MD

CONTACT

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

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

NCT05738694

Renal Cell CarcinomaNeoadjuvant

View study

RECRUITINGPHASE1

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

NCT04511039

Advanced Malignant Solid NeoplasmClinical Stage III Gastroesophageal Junction Adenocarcinoma+27 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 21, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

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