Intrapleural BG00001 In Treating Patients With Malignant Pleural Mesothelioma Or Malignant Pleural Effusions

Study Overview

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

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.

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.

Cancer

BIOLOGICAL: recombinant adenovirus-hIFN-beta

CDR0000315899
UPCC-01502

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2003-08-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-05-12
First Submitted that Met QC Criteria 2003-08-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-05-13
First Posted (ACTUAL) 2003-08-07	Results First Posted N/A	Last Verified 2020-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Not specified

ECOG 0-1

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Daniel H. Sterman, MD, Abramson Cancer Center at Penn Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Sterman DH, Recio A, Haas AR, Vachani A, Katz SI, Gillespie CT, Cheng G, Sun J, Moon E, Pereira L, Wang X, Heitjan DF, Litzky L, June CH, Vonderheide RH, Carroll RG, Albelda SM. A phase I trial of repeated intrapleural adenoviral-mediated interferon-beta gene transfer for mesothelioma and metastatic pleural effusions. Mol Ther. 2010 Apr;18(4):852-60. doi: 10.1038/mt.2009.309. Epub 2010 Jan 12.

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Clinical Trial Record