Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066404
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : May 13, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:

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 malignant pleural effusions.

Condition or disease Intervention/treatment Phase
Cancer Biological: recombinant adenovirus-hIFN-beta Phase 1

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
Study Start Date : April 2003
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hematocrit at least 30% (transfusion allowed)


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 1.5 times ULN
  • PT and PTT no greater than 1.5 times normal
  • No end-stage liver disease
  • No chronic active hepatitis B (hepatitis B surface antigen negative)


  • Creatinine no greater than 2.0 mg/dL
  • No end-stage renal disease


  • No unstable angina


  • FEV_1 greater than 50% of predicted (post-pleural drainage)
  • No severe oxygen-dependent chronic obstructive pulmonary disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No documented immunodeficiency
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or successfully treated localized malignancy of the bladder or prostate gland with no evidence of active disease
  • No other life-threatening illness
  • No known hypersensitivity to any component of study treatment


Biologic therapy

  • More than 4 weeks since prior biologic therapy
  • No prior bone marrow transplantation, including stem cells
  • No immunological drugs during and for at least 2 months after study therapy


  • See Disease Characteristics
  • No chemotherapy during and for at least 2 months after study therapy

Endocrine therapy

  • See Disease Characteristics
  • Concurrent hormonal therapy allowed if maintained at dose received prior to study entry
  • No concurrent steroids


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No radiotherapy during and for at least 2 months after study therapy


  • At least 2 weeks since prior surgery


  • More than 4 weeks since prior cytotoxic agents
  • No concurrent immunosuppressives or medication that can directly or indirectly suppress the immune system
  • No other concurrent experimental therapies for pleural cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066404

Layout table for location information
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Daniel H. Sterman, MD Abramson Cancer Center of the University of Pennsylvania
Publications of Results:
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00066404    
Other Study ID Numbers: CDR0000315899
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
advanced malignant mesothelioma
male breast cancer
localized malignant mesothelioma
recurrent bladder cancer
recurrent renal cell cancer
recurrent urethral cancer
recurrent breast cancer
recurrent penile cancer
recurrent prostate cancer
recurrent anal cancer
recurrent colon cancer
recurrent esophageal cancer
recurrent gastric cancer
recurrent pancreatic cancer
recurrent rectal cancer
recurrent gastrointestinal carcinoid tumor
recurrent small intestine cancer
recurrent gallbladder cancer
recurrent extrahepatic bile duct cancer
recurrent adult primary liver cancer
recurrent non-small cell lung cancer
recurrent small cell lung cancer
recurrent thymoma and thymic carcinoma
recurrent melanoma
recurrent malignant mesothelioma
recurrent malignant testicular germ cell tumor
recurrent cervical cancer
recurrent ovarian epithelial cancer
fallopian tube cancer
recurrent vulvar cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Pleural Effusion, Malignant
Pleural Effusion
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Respiratory Tract Diseases
Pleural Diseases