Trial Information

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

Mohammad Ghalib
Einstein-Montefiore Institute for Clinical & Translational Research
Montefiore Medical Center
Department of Oncology
111 East 210th Street
Bronx, NY 10467
Phone: 718-405-8515
Email: MHGHALIB@montefiore.org

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Research Center Information: Einstein-Montefiore Institute for Clinical & Translational Research

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