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
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Sarika Jain
- A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
- A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy
- A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Men and Postmenopausal Women with Hormone Receptor-Positive Advanced Breast Cancer
- A Phase I Study of BYL719 and Trastuzumab-MCC-DM1 in HER2-Positive Metastatic Breast Cancer Patients with Progression on Prior Trastuzumab and Taxane-Based Therapy
- SWOG 1207: Phase-III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study - evaluating everolimus with endocrine therapy
last updated: 01-Dec-15 08:38 AM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.