drugset / Trial / NCT00217373
Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)
NaSingle-groupOpen-labelTreatment
Summary
This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metastatic cancer that makes CEA. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells that make carcinoembryonic antigen (CEA). Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Interferon alfa-2b may interfere with the growth of cancer cells and slow cancer growth. Giving vaccine therapy together with GM-CSF and interferon alfa-2b may kill more cancer cells that make CEA.
Timeline
- Start
- 2005-06
- Primary completion
- 2013-01
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | — | Subcutaneous |
| Background | Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine | Vaccine | — | Subcutaneous |
| Background | recombinant vaccinia-CEA(6D)-TRICOM vaccine | Vaccine | — | Subcutaneous |
| Background | sargramostim | Protein / enzyme biologic | — | Subcutaneous |