A Phase I Study of Intratumoral Clostridium novyi-NT Spores in Patients with Persistent Solid Tumors

Protocol
14-087
Full Title
Phase I Safety Study of Intratumoral Injection of Clostridium novyi-NT Spores in Patients with Treatment-Refractory Solid Tumor Malignancies
Phase
I
Purpose

Clostridium novyi (C. novyi)-NT is a modified form of a bacterium found in soil. Laboratory studies have shown that when C. novyi-NT spores are injected directly into tumors, the bacteria can grow and kill a large part of the tumors.

In this study, researchers want to find the highest dose of C. novyi-NT spores that can be injected into the tumors of patients whose cancers are continuing to grow despite standard treatment or for which no standard treatment exists. Patients will receive a single injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have solid tumors 1 cm or more in diameter that have continued to grow despite at least one prior regimen of standard therapy, or tumors for which no standard therapy exists. Patients can have multiple tumors, but the tumor that will be targeted for injection has to be less than 12 cm in maximum dimension and located in the extremities, abdominal wall, or chest wall. Tumors deep inside the abdomen, pelvis, lung, or regions of the head will not be injected.
  • Patients must have a caregiver for 28 days after receiving the injection.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4226.

Disease(s)
Solid Tumors
Locations