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Interferon

High-Dose Interferon Alfa for Melanoma

Phase 3
Waitlist Available
Led By Alberto S. Pappo, MD
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)
Histologically confirmed primary melanoma of cutaneous origin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for 2 years, every 6 months for 3 years
Awards & highlights

Study Summary

This trial is comparing high dose interferon alfa to observation only in treating patients with stage II or stage III melanoma.

Who is the study for?
This trial is for adults over 18 with stage II or III melanoma that's been surgically removed. They must have good organ function, no other cancers in the past 5 years, and not be pregnant or nursing. Participants need to use effective contraception and can't have autoimmune disorders, heart failure, a history of stroke or ischemic heart disease, cognitive impairments, or be on immunosuppressive treatments.Check my eligibility
What is being tested?
The study is testing high-dose interferon alfa against just observation to see which is better at preventing cancer growth after surgery. Patients are randomly assigned to either get the drug treatment or undergo regular monitoring without additional therapy.See study design
What are the potential side effects?
Interferon alfa can cause flu-like symptoms (fever, chills), fatigue, decreased appetite, skin reactions at the injection site, liver problems (elevated liver enzymes), blood cell count changes (which could increase infection risk), and may affect mood causing depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.
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My skin cancer is confirmed as melanoma.
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My lymph nodes do not show signs of cancer, either by clinical exam or biopsy.
Select...
My cancer is stage III with a tumor thicker than 4mm or has spread to one lymph node.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months for 2 years, every 6 months for 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, every 6 months for 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
5-year Relapse-free Survival Rate
Secondary outcome measures
5-year Overall Survival Rate

Side effects data

From 2012 Phase 2 trial • 116 Patients • NCT00919633
64%
Fatigue
60%
Nausea
60%
Headache
44%
Depression
40%
Pyrexia
40%
Alopecia
32%
Influenza Like Illness
32%
Cough
28%
Myalgia
28%
Rash
24%
Chills
24%
Insomnia
24%
Dizziness
24%
Muscle Spasms
20%
Neutropenia
20%
Anaemia
20%
Thrombocytopenia
20%
Irritability
20%
Upper Respiratory Tract Infection
20%
Decreased Appetite
16%
Diarrhoea
16%
Anxiety
16%
Pain
16%
Bronchitis
16%
Dyspnoea
16%
Dry Skin
12%
Photophobia
12%
Respiratory Tract Congestion
12%
Techycardia
8%
Back Pain
8%
Pruritus
8%
Syncope
8%
Leukopenia
8%
Ear Pain
8%
Visual Acuity Reduced
8%
Abdominal Pain
8%
Vomiting
8%
Confusional State
8%
Weight Decreased
8%
Retinal Exudates
8%
Pneumonia
8%
Non-Cardiac Chest Pain
8%
Disturbance in Attention
8%
Memory Impairment
8%
Sinusitis
8%
Productive Cough
8%
Oropharyngeal Pain
8%
Dehydration
4%
Dry Eye
4%
Dysgeusia
4%
Epistaxis
4%
Dyspepsia
4%
Eye Pain
4%
Type 2 Diabetes Mellitus
4%
Constipation
4%
Stomatitis
4%
Arthralgia
4%
Nasal Congestion
4%
Sinus Congestion
4%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
INTRON A 80,000
INTRON A 120,000
INTRON A 160,000
PEGINTRON 1.5

Trial Design

2Treatment groups
Experimental Treatment
Group I: ObservationExperimental Treatment1 Intervention
Patients undergo observation for 4 weeks.
Group II: Interferon Alfa-2bExperimental Treatment1 Intervention
Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
interferon alfa-2b
2009
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
260,111 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
175,772 Total Patients Enrolled
SWOG Cancer Research NetworkNETWORK
394 Previous Clinical Trials
263,470 Total Patients Enrolled

Media Library

Interferon alfa-2b (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT00003641 — Phase 3
Skin Cancer Research Study Groups: Interferon Alfa-2b, Observation
Skin Cancer Clinical Trial 2023: Interferon alfa-2b Highlights & Side Effects. Trial Name: NCT00003641 — Phase 3
Interferon alfa-2b (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003641 — Phase 3
~44 spots leftby Jun 2025
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