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Therapeutic Areas: Oncology | Family Medicine
Disease Category: Solid Tumors
Location: United States, NY

Clinical Trial Details


Research Study Summary

Phase I Safety Study of Clostridium Novyi-NT Spores in Patients with Treatment-Refractory Solid Tumor Malignancies


This research is being done to study whether Clostridium novyi-NT (non-toxin producing) spores are safe and work well in people with advanced cancers that can no longer be controlled with standard therapy. Clostridium novyi-NT is bacteria. In laboratory animals, Clostridium novyi-NT spores can grow within tumors and destroy a large part of the tumors. Individuals who are eligible to be in the study will be admitted to the hospital for at least 8 days, where they will receive Clostridium novyi-NT spores through a one-time intravenous (into the vein) injection.

Patient Inclusion Criteria:

  • Must have a diagnosed solid tumor malignancy
  • Refractory to standard chemotherapy or at least one line of therapy in those patients for whom no standard treatment exists
  • Has measurable disease (defined as at least one lesion whose longest diameter can be accurately measured as > 1 cm)
  • At least 4 weeks has elapsed since the completion of major surgery, and the patient is fully recovered from this surgery and any post-surgical complications
  • Patient is at least 18 years of age

Patient Exclusion Criteria:

  • Positive pregnancy test
  • Has a serum creatinine level > 1.5 times the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis

To Learn more



Both Male and Female


18 and up

Overall Status


Facility Type



Mohammad Ghalib
The Harold & Muriel Block Institute for Clinical and Translational Research at Einstein & Montefiore
Montefiore Medical Center
Department of Oncology
111 East 210th Street
Bronx, NY 10467
Phone: 718-405-8515

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 181290

Date Last Changed: July 18, 2013

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