Clinical Trial ECOG 3611
- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- Principal Investigator
- Timothy Kuzel
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 3611
- The purpose of this study is to compare the good and bad effects of ipilimumab either alone or in combination with interferon alfa-2b on patients and their melanoma.
- Ipilimumab is approved by the FDA at a dose of 3 mg/kg, given for a total of 4 doses, 3 weeks apart, for metastatic melanoma that cannot be treated using surgery; however, only some patients benefit from this treatment. Interferon alfa-2b is FDA-approved as an adjuvant treatment to surgery in adult patients with melanoma who are free of disease but at high risk for it coming back. Early data from a recently published study have shown that the combination of interferon alfa-2b and tremelimumab (an antibody that works similarly to ipilimumab) is safe and has promising anti-melanoma activity that is superior to the use of tremelimumab alone. That study has provided support for pursuing the combination of interferon alfa-2b and ipilimumab.
Some of the eligibility criteria include:
- Participants must have melanoma that cannot be treated with surgery.
- Participants must be 18 or older.
- Participants may have had only one prior systemic therapy for their advanced disease.
- Description of Treatment
- Participants will be "randomized" into one of four study groups. Two groups will get both ipilimumab (two different doses are given) and interferon. Two groups will get ipilimumab only (two different doses are given). Participants in the ipilimumab + interferon alfa-2b groups will receive ipilimumab that will be given in 2 stages called induction phase and maintenance phase. In the induction phase, participants will receive iplimumab every 3 weeks for a maximum of 4 doses. In the maintenance phase, participants will receive iplimumab every 12 weeks (3 months), beginning at week 24, for a maximum of 4 doses (weeks 24, 36, 48, 60). In addition to ipilimumab, participants will receive interferon Alfa-2b, also given in 2 stages called induction phase and maintenance phase. In the induction phase, participants will receive interferon Alfa-2b given 5 days in a row (M-F) out every week, for four weeks. This is given by IV (given in the vein) over 20 minutes. After four weeks, participants will receive Alfa-2b under the skin every other day (M, W, F) each week for eight weeks. In the maintenance phase, participants will receive interferon Alfa-2b three times weekly, every other day (M, W, F) for 48 weeks by injections under the skin. Participants in the ipilimumab alone groups will receive ipilimumab that will be given in 2 stages called induction phase and maintenance phase, in the same way as described above. In both arms, Ipilimumab will be administered by IV over 90 minutes.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
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- A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
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last updated: 22-May-15 12:34 PM
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