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Mesothelioma Clinical Trials

Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions

This study is currently recruiting patients.

Sponsored by

University of Pennsylvania Cancer Center
For more information:National Cancer Institute (NCI)

RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural cavity may improve the body's ability to fight cancer.

PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating patients who have malignant pleural mesothelioma or malignantpleural effusions.

Condition Treatment or Intervention
 Drug: BG00001
 Procedure: gene therapy

This is a Phase I test

  • In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Intrapleural BG00001 in Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions

Further Study Details: 


  • Determine the safety and toxicity of intrapleural BG00001 in patients with malignant pleural mesothelioma or malignant pleural effusions.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the success of gene transfer/interferon beta gene expression in patients treated with this drug.
  • Determine systemic and intrapleural cytokine responses and cellular and humoral immune response in patients treated with this drug.
  • Determine, preliminarily, tumor response in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive BG00001 via an intrapleural catheter on day 1.

Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

Patients are followed weekly for 1 month, biweekly for 1 month, monthly for 4 months, and then every 6 months for 15 years.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • One of the following histologically or cytologically confirmed diagnoses:
  • Malignant pleural mesothelioma
  • Metastatic malignancy to the pleural space
  • Originating from 1 of the following sites:
  • Lung
  • Breast
  • Gastrointestinal organs
  • Genitourinary organs
  • Malignant melanoma
  • Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy
  • Measurable or evaluable disease
  • Pleural space involved with tumor accessible for pleural catheter insertion
  • No malignant pleural effusions secondary to lymphoma or sarcoma
  • No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis
  • No known brain metastases
  • Previously treated brain metastases with no evidence of active growth are allowed
  • Hormone receptor status:
  • Not specified

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