Study on Ipilimumab or High-Dose Interferon Alfa-2b for Treating High-Risk Stage III-IV Melanoma After Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01274338
This clinical trial is comparing two treatments, ipilimumab and high-dose interferon alfa-2b, to see which is more effective in preventing the return of high-risk stage III-IV melanoma after it has been surgically removed.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing two different treatments to see which one works better for patients with high-risk stage III-IV melanoma that has been removed by surgery. The treatments being compared are ipilimumab, an immunotherapy drug that helps the immune system attack cancer cells, and high-dose interferon alfa-2b, which may slow the growth of cancer cells. The goal is to find out which treatment is more effective in preventing the cancer from coming back and improving survival rates.
Description
The study is divided into several parts to evaluate the effectiveness and safety of the treatments. Patients are randomly assigned to receive either high-dose ipilimumab, low-dose ipilimumab, or high-dose interferon alfa-2b. The study will measure how long patients remain free of cancer and their overall survival rates. It will also assess the safety and side effects of the treatments.
Patients will receive their assigned treatment in cycles, with ipilimumab given intravenously every 21 days for four cycles, followed by maintenance doses every 90 days. Interferon alfa-2b is given intravenously and then subcutaneously for a total of 48 weeks. After completing the treatment, patients will have regular follow-up visits to monitor their health and check for any signs of cancer returning.
The study also aims to evaluate the quality of life of patients receiving these treatments, particularly focusing on any side effects that may impact their daily lives.
Eligibility Criteria
Inclusion Criteria
- Must have had surgery to remove melanoma and be free of disease as confirmed by physical exams and imaging tests.
- Must have stage IIIB, IIIC, or stage IV melanoma, with specific criteria for each stage.
- Must be randomized within 12 weeks of the last surgery.
- Must have a good performance status, meaning they are fully active or able to carry out light work.
- Must not have any active infections or other significant medical conditions that could interfere with the study.
- Women of childbearing potential must use effective contraception during the study and for 26 weeks after the last dose.
- Must have adequate blood counts and organ function as determined by specific blood tests.
- Must not have received any other adjuvant treatment after surgery, except for radiation therapy completed at least 21 days before starting the study treatment.
Exclusion Criteria
- Must not have received prior treatment with certain immune therapies or interferon-alfa.
- Must not have active infections requiring treatment with antibiotics.
- Must not have significant medical, surgical, or psychiatric conditions that could interfere with the study.
- Must not have autoimmune disorders or conditions requiring ongoing treatment with systemic steroids.
- Must not be pregnant or breastfeeding.
- Must not have other current malignancies, except for certain non-threatening cancers that have been disease-free for over 5 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Providence Hospital | 36608 | Mobile | Alabama |
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| University of Arizona Cancer Center-Orange Grove Campus | 85704 | Tucson | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.