Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma
Summary
The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma. Primary Objective: * The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma. Secondary Objectives: * To assess responses to the combination. * To evaluate the duration of response and the overall survival. * To determine the effectiveness in delaying the appearance of Central Nervous System disease.
Timeline
- Start
- 2009-09
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 250 mg/m2 | Oral |
| Subject | aldesleukin | Protein / enzyme biologic | 9 unknown | Intravenous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 5 unknown | Subcutaneous |