E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α-2b for Resected High-Risk Melanoma
Aims: The purpose of this study to determine whether the experimental drug ipilimumab stops or delays high-risk melanoma from returning when compared to standard therapy. For high risk melanoma, the current standard treatment is to take high-dose interferon for a year, which causes a number of side effects, or take no treatment.  Ipilimumab has been approved by the FDA for use in advanced melanoma. However for high risk melanoma, ipilimumab is still investigational (not FDA approved). Based on prior trials in advanced melanoma, researchers hope that ipilimumab the will be of greater benefit and cause less side effects than interferon in resected high risk melanoma patients.
Diagnosis: Resected High-Risk Melanoma
Principal Investigator: Bruce Brockstein, MD
IRB Approval Number: EH12-072
Sponsor: Eastern Cooperative Oncology Group
Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698
Open to Enrollment: Yes

E3612: A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
Aims: The purpose of this research study is to compare the good and bad effects of using the study drug called ipilimumab either alone or in combination with the study drug called bevacizumab. This regimen could help improve how long you are able to live with your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach used to treat advanced melanoma. Ipilimumab is approved by the FDA at a dose of 3 mg/kg for a total of 4 doses given 3 weeks apart for metastatic melanoma that cannot all be removed or treated with surgery. Bevacizumab is not approved by the FDA to treat melanoma, and is an investigational treatment. There will be about 168 people taking part in this study. Ten of those patients will be from NorthShore University HealthSystem.
Diagnosis: Unresectable Stage III or Stage IV Melanoma
Principal Investigator: Bruce Brockstein, MD
IRB Approval Number: EH14-171
Sponsor: Eastern Cooperative Oncology Group
Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698
Open to Enrollment: Yes

 

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