drugset / Trial / NCT00358397
One Time Injection of Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy
NaSingle-groupOpen-labelTreatment
Summary
This study will include a one time intravenous (IV) infusion of Clostridium novyi-NT (C. novyi-NT) spores to treat solid tumors which have not responded to standard therapy.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-09
- Completion
- 2008-09
Publications
- Background Diaz LA Jr, Cheong I, Foss CA, Zhang X, Peters BA, Agrawal N, Bettegowda C, Karim B, Liu G, Khan K, Huang X, Kohli M, Dang LH, Hwang P, Vogelstein A, Garrett-Mayer E, Kobrin B, Pomper M, Zhou S, Kinzler KW, Vogelstein B, Huso DL. Pharmacologic and toxicologic evaluation of C. novyi-NT spores. Toxicol Sci. 2005 Dec;88(2):562-75. doi: 10.1093/toxsci/kfi316. Epub 2005 Sep 14.
- Background Folkman J. A novel anti-vascular therapy for cancer. Cancer Biol Ther. 2004 Mar;3(3):338-9. doi: 10.4161/cbt.3.3.708. Epub 2004 Mar 29. No abstract available.
- Background Dang LH, Bettegowda C, Agrawal N, Cheong I, Huso D, Frost P, Loganzo F, Greenberger L, Barkoczy J, Pettit GR, Smith AB 3rd, Gurulingappa H, Khan S, Parmigiani G, Kinzler KW, Zhou S, Vogelstein B. Targeting vascular and avascular compartments of tumors with C. novyi-NT and anti-microtubule agents. Cancer Biol Ther. 2004 Mar;3(3):326-37. doi: 10.4161/cbt.3.3.704. Epub 2004 Mar 12.
- Background Bettegowda C, Dang LH, Abrams R, Huso DL, Dillehay L, Cheong I, Agrawal N, Borzillary S, McCaffery JM, Watson EL, Lin KS, Bunz F, Baidoo K, Pomper MG, Kinzler KW, Vogelstein B, Zhou S. Overcoming the hypoxic barrier to radiation therapy with anaerobic bacteria. Proc Natl Acad Sci U S A. 2003 Dec 9;100(25):15083-8. doi: 10.1073/pnas.2036598100. Epub 2003 Dec 1.
- Background Dang LH, Bettegowda C, Huso DL, Kinzler KW, Vogelstein B. Combination bacteriolytic therapy for the treatment of experimental tumors. Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):15155-60. doi: 10.1073/pnas.251543698. Epub 2001 Nov 27.
- Background Agrawal N, Bettegowda C, Cheong I, Geschwind JF, Drake CG, Hipkiss EL, Tatsumi M, Dang LH, Diaz LA Jr, Pomper M, Abusedera M, Wahl RL, Kinzler KW, Zhou S, Huso DL, Vogelstein B. Bacteriolytic therapy can generate a potent immune response against experimental tumors. Proc Natl Acad Sci U S A. 2004 Oct 19;101(42):15172-7. doi: 10.1073/pnas.0406242101. Epub 2004 Oct 7.
- Background Jain RK, Forbes NS. Can engineered bacteria help control cancer? Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):14748-50. doi: 10.1073/pnas.261606598. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clostridium novyi-NT | Other / unclassified | — | Intravenous |