A Phase I Study of GL-ONC1 for Treating Malignant Pleural Effusion

Protocol
12-169
Full Title
Phase I Study of Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients with Malignant Pleural Effusion: Primary, Metastases and Mesothelioma
Phase
I
Purpose

Malignant pleural effusion is a build-up of fluid in the chest that can develop in some patients with mesothelioma or other cancers in the chest. In this study, researchers are determining the highest dose of an investigational drug called GL-ONC1 that can be given safely in patients with malignant pleural effusion due to pleural mesothelioma, primary lung cancer, or lung metastases.

GL-ONC1 is a modified, weakened strain of a virus called vaccinia. It is designed to locate, enter, and destroy cancer cells without harming healthy tissues. Laboratory studies showed that GL-ONC1 targeted and killed cancer cells.

Eligibility

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

  • Patients must have malignant pleural effusion as a result of pleural mesothelioma, primary lung cancer, or lung metastases.
  • At least 2 weeks must have passed since the completion of prior therapy and entry into the study. Small field radiation therapy is permitted.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patient ages 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Valerie W. Rusch at 212-639-5873.

Disease(s)
Breast Cancer
Lung Cancer
Lung Cancer, Non-Small Cell
Lung Cancer, Small Cell
Mesothelioma
Locations

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