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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00226408

Enrollment

600

Registered

2005-09-27

Start date

2003-11-30

Completion date

2005-09-30

Last updated

2006-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant, Stage III Malignant Melanoma, Interferon Alpha, Therapy

Keywords

melanoma,adjuvant therapy,stageIII Interferon, high dose

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

Interventions

DRUGInterferon-alpha-2b

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
distant metastasis free survival/(DMFI )	—

Secondary

Measure	Time frame
overall survival	—
time to progression	—
toxicity	—

Countries

Germany

Contacts

Primary ContactPeter Mohr, MD

p.mohr@elbekliniken.de0049 41261 703

Backup ContactMichael Weichenthal, MD

mweichenthal@dermatology.uni-kiel.de0049 431 597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026