Clinical Trial ECOG 1609
- A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma
- Principal Investigator
- Timothy Kuzel
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 1609
- The purpose of this study is to compare the effects of ipilimumab with interferon alfa-2b on patients with melanoma to find out which is better.
- Participants in this study have skin cancer (melanoma) which, although it has been successfully treated with surgery, has a high probability of coming back. Participants will get either ipilimumab or the interferon alfa-2b, not both. High doses of interferon alfa-2b can reduce the risk of melanoma returning, but only some patients benefit from interferon. Ipilimumab is a drug that has been shown to have anti-tumor activity in advanced melanoma. Ipilimumab is investigational which means that it has not been approved by the FDA.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age.
- Participants must have skin cancer (melanoma), which has been successfully treated with surgery, but has a high probability of coming back.
- Participants must not have received any previous treatment (chemotherapy, biotherapy, etc.).
- Description of Treatment
- Participants will be placed randomly into one of the study groups described below. Neither participant nor doctor can choose the group. Participants will have an equal chance of being placed in any group. Participants in group 1 will receive ipilimumab that will be given through the vein. Participants in group 2 will be given interferon Alfa-2b through the vein. These will be administered in 2 stages called induction phase and maintenance phase. The dose and frequency of each dose will vary depending on which phase of the study the participant is in. During the maintenance phase for group 2, participants will be taught how to self administer the injection of the drug.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
- A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy
- A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
- 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 Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- 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: 01-Nov-14 08:51 AM
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