Clinical Trial DRUG BVD-CNV2
- Phase I Safety Study of Intratumoral Injection of Clostridium novyi-NT Spores in Patients with Treatment-Refractory Solid Tumor Malignancies
- Principal Investigator
- Sarika Jain
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG BVD-CNV2
- This study is being done to learn whether the study drug, Clostridium novyi-NT spores (NT refers to non-toxin producing), is safe and effective in patients with advanced cancers that can no longer be controlled with standard therapy or cancers for which there is no standard effective treatment.
- The use of Clostridium novyi-NT (C.novyi-NT) spores in this research study is investigational. The word “investigational” means that C.novyi-NT spores are not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of C.novyi-NT spores in this study. C. novyi-NT spores are bacteria. In laboratory animals, C.novyi-NT spores grow within tumors and destroy a large part of the tumors. –Naturally occurring C. novyi with the lethal toxin is naturally present in soil and can cause human disease; but for this study, a modified (changed) form called Clostridium novyi-NT, with the lethal toxin removed, will be used.
Some of the eligibility criteria include:
- Study participants must have an advanced solid tumor malignancy.
- Participants must have had at least one prior systemic treatment, and no other curative options are available for continued treatment.
- Participants must be 18 or older.
- Description of Treatment
- Participants in the study will be admitted to the hospital for a total of 8 days. While in the hospital the participant will receive one injection of the study drug into the tumor. After participants leave the hospital they will continue to be followed closely by the study doctor.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 29-May-16 06:31 AM
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