Spots Global Cancer Trial Database for One Time Injection of Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy

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Trial Identification

Brief Title: One Time Injection of Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy

Official Title: Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-Refractory Solid Tumor Malignancies

Study ID: NCT00358397

Conditions

Tumors

Interventions

Clostridium novyi-NT spores

Study Description

Brief 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.

Detailed Description: 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.