Clinical trialPhase 1Terminated
One Time Injection of Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy
Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-Refractory Solid Tumor Malignancies
- Outcome
- Stopped earlyDesign Problem (Other)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- July 2006
- Expected end
- September 2008
- Enrollment
- 2 participants
- Sites
- 1
- Primary outcomes
- To determine the safety profile, dose limiting toxicities (DLT), and maximum tolerated dose (MTD) of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
- Sponsor
- Other
- Results posted
- No
- Last update
- 14 October 2016
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Investigators at the SKCCC have developed a bacterial strain (C. novyi-NT) that can infect tumors and destroy them, but does not grow in normal tissues. In animal experiments, a single intravenous injection of these bacteria can cause dramatic regression of many tumors, and the tumors do not recur in approximately (\~) 30% of the animals. This is a phase I dose escalation study using a single dose of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. The overall objective of this study is to determine the safety and document any preliminary evidence of anti-tumor activity in this patient population.