Study on High-Dose Interferon Alfa for Patients with Stage II or III Melanoma
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT00003641
This clinical trial is exploring whether high-dose interferon alfa can help prevent the return of melanoma after surgery in patients with stage II or III melanoma. The study compares this treatment to simply observing patients after their cancer has been surgically removed.
Patient Parameters
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Program Overview
The purpose of this study is to find out if high-dose interferon alfa can help stop melanoma from coming back after surgery in patients with stage II or III melanoma. Researchers want to see if this treatment is more effective than just monitoring patients after their cancer has been removed.
Description
This study aims to compare the effects of high-dose interferon alfa-2b on the time patients remain free from melanoma returning after surgery. It also looks at how this treatment affects overall survival, any side effects, and the quality of life of patients.
Participants are divided into two groups:
- Group 1 (Observation): Patients are monitored for 4 weeks without additional treatment.
- Group 2 (Interferon Alfa-2b): Patients receive high-dose interferon alfa-2b through an IV for 20 minutes daily over 5 days each week, for 4 weeks, unless side effects are too severe.
Quality of life is assessed before treatment, on day 22, every 3 months for 2 years, and then every 6 months for 3 years. Patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 15 years after joining the study.
The study plans to enroll 1,420 patients over 5 years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage II or III melanoma that has been surgically removed.
- Must meet specific criteria based on the thickness and characteristics of the melanoma.
- Completed all primary treatments, including surgery, within 84 days before joining the study.
- Aged 18 or older (10 or older for certain patients).
- Good overall health with an ECOG performance status of 0 or 1.
- Adequate blood cell counts and organ function based on specific tests.
- No other cancers in the past 5 years, except for certain non-threatening types.
- Negative pregnancy test for women of childbearing potential.
- Agree to use effective contraception during and for 6 months after the study.
Exclusion Criteria
- Evidence of melanoma that was not completely removed or has spread.
- Enlarged lymph nodes that can be felt during a physical exam.
- Significant mental health issues or other medical conditions that would interfere with the study.
- Pregnant or breastfeeding.
- History of other invasive melanoma or autoimmune disorders.
- Heart disease or stroke history.
- Previous chemotherapy, immunotherapy, or radiotherapy for melanoma.
- Use of systemic corticosteroids or other immunosuppressive medications.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UAB Comprehensive Cancer Center | 35294 | Birmingham | Alabama |
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Arizona Cancer Center at University of Arizona Health Sciences Center | 85724-5024 | Tucson | Arizona |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | 72903 | Fort Smith | Arkansas |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente - Deer Valley | 94531 | Antioch | California |
| Alta Bates Summit Comprehensive Cancer Center | 94704 | Berkeley | California |
| Peninsula Medical Center | 94010 | Burlingame | California |
| Southern California Permanente Medical Group | 90027 | Downey | California |
| Kaiser Permanente - Fremont | 94538 | Fremont | California |
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