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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

Must not have

Clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease; Clinically palpable lymphadenopathy; Evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation; Other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation; Pregnant or nursing; Other history of invasive melanoma; Autoimmune disorders or conditions of immunosuppression; History of active ischemic heart disease; Cerebrovascular disease; Congestive heart failure (New York Heart Association class III or IV heart disease); Prior or concurrent chemotherapy; Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma; Concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers; Prior or concurrent radiotherapy; Other concurrent immunosuppressive medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for 2 years, every 6 months for 3 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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

Select...

My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.

Select...

My skin cancer is confirmed as melanoma.

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for 2 years, every 6 months for 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

5-year Relapse-free Survival Rate

Secondary study objectives

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%

Thrombocytopenia

20%

Neutropenia

20%

Anaemia

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

Pruritus

Ear Pain

Leukopenia

Abdominal Pain

Syncope

Back Pain

Visual Acuity Reduced

Vomiting

Confusional State

Weight Decreased

Retinal Exudates

Pneumonia

Non-Cardiac Chest Pain

Disturbance in Attention

Memory Impairment

Sinusitis

Productive Cough

Oropharyngeal Pain

Dehydration

Epistaxis

Dry Eye

Eye Pain

Dyspepsia

Dysgeusia

Type 2 Diabetes Mellitus

Constipation

Stomatitis

Arthralgia

Nasal Congestion

Sinus Congestion

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

INTRON A 80,000

INTRON A 120,000

INTRON A 160,000

PEGINTRON 1.5

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met