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A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies

Phase 1
18 Years
Open (Enrolling)

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Trial Information

A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies


- 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.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Daniel H. Sterman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

Related Keywords:

  • Cancer
  • 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
  • recurrent vaginal cancer
  • recurrent gestational trophoblastic tumor
  • recurrent endometrial carcinoma
  • recurrent ovarian germ cell tumor
  • malignant pleural effusion
  • Mesothelioma
  • Pleural Effusion
  • Pleural Effusion, Malignant



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283