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CompletedPhase 1NCT00299962
Official study title

Gene Therapy for Pleural Malignancies

Study summary

This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have: * malignant pleural mesothelioma, or * pleural effusions who have progressed through at least one prior therapy or have refused therapy BG00001 is given twice through a catheter in the pleural space.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAdenoviral-mediated Interferon-beta and SCH 721015

The study team can explain what participation involves.

Who it may be forMesothelioma · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 18, 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?University of Pennsylvania

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
University of Pennsylvania
Interventions being studied
Biological: Adenoviral-mediated Interferon-beta; Biological: SCH 721015
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→
Disease setting
Metastatic or stage IV→
Treatment approach
Cell or gene therapy→
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
  • must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
  • must have evaluable disease
  • must have ECOG performance status of 2
  • must have pleural space involved with tumor accessible for pleural catheter
  • must have FEV1 \> 1 liter or 40% of predicted value
  • must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001
  • concurrent Tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events
  • patients on stable dose of hormone may continue use of hormone
  • patients on stable dose of Tarceva for 3 months and without complications may remain on Tarceva
Reasons someone may not be able to joinExclusion criteria
  • malignant pleural effusions secondary to lymphoma
  • rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
  • untreated brain metastases
  • use of concurrent systemic steroids or immunosuppressants

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

  • Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 18, 2020. Always confirm current availability with the study team.

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