Mesothelioma Clinical Trials
Intrapleural
BG00001 in Treating Patients With Malignant Pleural
Mesothelioma or Malignant Pleural
Effusions
This study is currently
recruiting patients.
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 |
Cancer
|
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:
OBJECTIVES:
- 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
DISEASE CHARACTERISTICS:
- 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
|