drugset / Trial / NCT01266603
High-Dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2), when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be studied. Researchers will also use samples of the original tumor or metastatic tissue (for example, lymph nodes or liver or lung) that are collected during screening to study if response to the study drug is related to the genes in the tissue.
Timeline
- Start
- 2011-02-22
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 720000 iu/kg | Intravenous |
| Subject | recMAGE-A3 | Protein / enzyme biologic | 300 ug | Other |
| Background | agatolimod | Oligonucleotide (other) | 420 ug | Other |