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

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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
Phase

1

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

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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