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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00358397 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumors |
Drug: Clostridium novyi-NT spores |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-Refractory Solid Tumor Malignancies |
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria -
Screening physical exam must be obtained less than 7 days prior to treatment and the results must meet the following criteria:
Screening laboratory tests will be obtained less than 7 days prior to treatment and the results must meet the following criteria:
Exclusion Criteria -
Any evidence of serious infections (such as pneumonia or pyelonephritis) or history of chronic or recurrent infectious disease in the previous 3 months.
Less serious infections (such as acute upper respiratory tract infection(colds)or simple urinary tract infection) can be included upon the discretion of the investigator.
History of a significant medical illness deemed by the principal investigator or sub-investigators as unsuitable for the trial - for example:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Medical Institutes | |
| Baltimore, Maryland, United States, 21231 | |
| Principal Investigator: | Luis A Diaz, MD | Johns Hopkins Medicine |
More Information
| Responsible Party: | Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center ( Luis Diaz, MD ) |
| Study ID Numbers: | J0590 |
| Study First Received: | July 27, 2006 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00358397 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Solid Tumor Clostridial Spore-forming bacteria hypoxia anaerobes Clostridium novyi Bacteria Bacteriolytic Tumor lysis Necrosis |
Colon Cancer Lung Cancer Sarcoma Bladder Cancer Rectal Cancer Gastric Cancer Pancreatic Cancer Experimental Therapy Solid Tumors |