IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma
Summary
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma. Note: The study was closed following Phase I enrollment. Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer. Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells. Cisplatin is designed to poison the cancer cells, which may cause them to die.
Timeline
- Start
- 2013-02
- Primary completion
- 2016-05
- Completion
- 2016-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Temozolomide | Small molecule | 200 mg/m2 | Oral |
| Background | aldesleukin | Protein / enzyme biologic | 9 unknown | Intravenous |
| Background | interferon alfa-2b | Protein / enzyme biologic | 5 unknown | Subcutaneous |