drugset / Trial / NCT00668382
Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection
NaSingle-groupOpen-label
Summary
This is a Phase I pilot study to evaluate the toxicity and feasibility of intratumoral injection (Glycosphingolipids) GSL alpha-GAL (beta-galactosidase) in patients with advanced, refractory solid tumors who have failed standard therapies or are not eligible for standard treatment.
Timeline
- Start
- 2007-07
- Primary completion
- 2011-07
- Completion
- 2011-07
Publications
- Results Lugade AA, Moran JP, Gerber SA, Rose RC, Frelinger JG, Lord EM. Local radiation therapy of B16 melanoma tumors increases the generation of tumor antigen-specific effector cells that traffic to the tumor. J Immunol. 2005 Jun 15;174(12):7516-23. doi: 10.4049/jimmunol.174.12.7516.
- Results Malmberg KJ. Effective immunotherapy against cancer: a question of overcoming immune suppression and immune escape? Cancer Immunol Immunother. 2004 Oct;53(10):879-92. doi: 10.1007/s00262-004-0577-x. Epub 2004 Jul 28.
- Results DiGiacomo A, North RJ. T cell suppressors of antitumor immunity. The production of Ly-1-,2+ suppressors of delayed sensitivity precedes the production of suppressors of protective immunity. J Exp Med. 1986 Oct 1;164(4):1179-92. doi: 10.1084/jem.164.4.1179.
- Results Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha-Gal Glycosphingolipid | Unknown | 0.1 mg | Other |
| Subject | Alpha-Gal Glycosphingolipid | Unknown | 1 mg | Other |
| Subject | Alpha-Gal Glycosphingolipid | Unknown | 10 mg | Other |