A Phase I Study of Telomelysin Added to Chemoradiation for Patients with Advanced Inoperable Esophageal Cancer

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Full Title

Phase I Trial with Expansion Cohort of OBP-301 (Telomelysin) and Definitive Chemoradiation for Patients with Locally Advanced Esophageal and Gastroesophageal Adenocarcinoma Who Are Not Candidates for Surgery (NRG GI007) (CIRB)

Purpose

In this study, researchers want to assess the safety of adding the investigational therapy telomelysin to standard therapy for inoperable esophageal cancer (combined chemotherapy and radiation therapy, or chemoradiation). It is hoped that telomelysin with chemoradiation is more effective than chemoradiation alone for controlling the growth of the cancer.

Telomelysin is a virus that has been designed to infect and destroy cancer cells. Patients will receive telomelysin injections directly into the tumor via endoscopy (a tube inserted down the throat) for a total of three times every 14 days. They will receive the first injection before starting chemotherapy (carboplatin and paclitaxel) and radiation therapy, and then they will receive the other two injections during the following weeks of chemoradiation.

Eligibility

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

  • Patients must have adenocarcinoma of the esophagus or the junction between the esophagus and stomach (gastroesophageal junction).
  • Patients may not be candidates for surgery and be planning to have chemoradiation.
  • Patients may not have previously received chemotherapy or radiation therapy for esophageal cancer.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Geoffrey Ku at 646-888-4588.

Protocol

20-354

Phase

I

Investigator

Co-Investigators