Safety Study of Live Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy
Summary
This protocol will examine the safety of treating subjects with Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This pilot study will investigate the safety of using a sepsis scoring system to determine when to initiate antibiotics in these patients.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Solid Tumor Malignancies
Intervention
Clostridium novyi-NT spores
Location
Sidney Kimmel Comprehensice Cancer Center
Baltimore
Maryland
United States
21231
Status
Recruiting
Source
Sidney Kimmel Comprehensive Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01118819
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:53-0400
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Medical and Biotech [MESH] Definitions
Lomustine
An alkylating agent of value against both hematologic malignancies and solid tumors.
Clostridium Septicum
A species of gram-positive bacteria in the family Clostridiaceae. Infections have a strong association with malignancies and also with GAS GANGRENE.
Spores, Bacterial
Heat and stain resistant, metabolically inactive bodies formed within the vegetative cells of bacteria of the genera Bacillus and Clostridium.
Clostridium Chauvoei
A species of gram-positive bacteria in the family Clostridiaceae isolated from infected CATTLE; SHEEP; and other animals. It causes blackleg in cattle and sheep and is transmitted through soil-borne spores.
Carcinoma, Ehrlich Tumor
A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.
