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

May 12, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • 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)

Renal

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

Cardiovascular

  • No unstable angina

Pulmonary

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • At least 2 weeks since prior surgery

Other

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

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

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Daniel H. Sterman, MD, Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 6, 2003

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimate)

August 7, 2003

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000315899
  • UPCC-01502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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