drugset / Trial / NCT00128622
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to the cancer cells. Vaccines made from a gene-modified virus and a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving denileukin diftitox together with vaccine therapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects of giving denileukin diftitox together with vaccine therapy in treating patients with metastatic cancer that expresses carcinoembryonic antigen.
Timeline
- Start
- 2005-09
- Primary completion
- 2007-03
- Completion
- 2009-05
Publications
- Background Schonfeld K, Mahnke K, Schallenberg S, et al.: Treatment of melanoma bearing individuals with ONTAK® depletes regulatory T cells resulting in an augmented immune response following vaccination. [Abstract] J Invest Dermatol 126 (Suppl S3): A-594, s101, 2006.
- Morse MA, Hobeika AC, Osada T, Serra D, Niedzwiecki D, Lyerly HK, Clay TM. Depletion of human regulatory T cells specifically enhances antigen-specific immune responses to cancer vaccines. Blood. 2008 Aug 1;112(3):610-8. doi: 10.1182/blood-2008-01-135319. Epub 2008 Jun 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | denileukin diftitox | Protein / enzyme biologic | — | Intravenous |
| Subject | recombinant fowlpox-CEA(6D)/TRICOM vaccine | Vaccine | — | Other |
| Subject | therapeutic autologous dendritic cells | Vaccine | — | Other |