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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Adjuvant, Stage III Malignant Melanoma, Interferon Alpha, Therapy

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

distant metastasis free survival/(DMFI )

Principal Investigator

Peter Mohr, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Elbeklinikum, Buxtehude, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

MM-ADJ-5

NCT ID:

NCT00226408

Start Date:

November 2003

Completion Date:

September 2005

Related Keywords:

  • Adjuvant
  • Stage III Malignant Melanoma
  • Interferon Alpha
  • Therapy
  • melanoma,adjuvant therapy,stageIII Interferon
  • high dose
  • Melanoma

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