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Interferon

PEG-interferon alfa-2b for Skin Cancer

Phase 2
Waitlist Available
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 9 weeks until suppression of plasma b-fgf level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. after off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Awards & highlights

Study Summary

RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.

Eligible Conditions
  • Skin Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 9 weeks until suppression of plasma b-fgf level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. after off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 9 weeks until suppression of plasma b-fgf level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. after off treatment, every 3 months if <2 years, and every 6 months if 2-3 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
Plasma b-FGF Level Response
Secondary outcome measures
Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)
Overall Survival
Progression Free Survival

Side effects data

From 2009 Phase 2 trial • 7 Patients • NCT00047879
50%
Fatigue
25%
Dry skin
25%
Mood alteration
25%
Seizure
25%
Metabolic, hyperglycemia
25%
Elevated AST
25%
AST
25%
Infection
25%
Elevated bilirubin
25%
Dizziness
25%
Pain, skin
25%
Fever
25%
Confusion
25%
Metabolic, ALT elevated
25%
Neurology, somnolence
25%
Rash
25%
Glucose
25%
Nausea
25%
Musculoskeletal, other leg/foot cramp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Glioblastoma Multiforme Stratum
Anaplastic Glioma Stratum

Trial Design

1Treatment groups
Experimental Treatment
Group I: PEG-interferon alfa-2bExperimental Treatment1 Intervention
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon alfa
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
151,563 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,697 Total Patients Enrolled
Ronald S. Go, MDStudy ChairGundersen Lutheran Center for Cancer and Blood
1 Previous Clinical Trials
8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby May 2025