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CompletedPhase 1NCT00066404
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedrecombinant adenovirus-hIFN-beta

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 13, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Abramson Cancer Center at Penn Medicine

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Abramson Cancer Center at Penn Medicine
Interventions being studied
Biological: recombinant adenovirus-hIFN-beta
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2020. Always confirm current availability with the study team.

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