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Completed

NCT Number: NCT00299962

Gene Therapy for Pleural Malignancies

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 information

Conditions

Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Metastatic Pleural Effusions Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Diseases Pleural Effusion Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.

Five dose levels will be studied:

  • Dose levels 1, 2, and 3 will be given on Days 1 and 15
  • Dose levels 4 and 5 will be given on Days 1 and 8

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion 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

Treatment and study plan

Adenoviral-mediated Interferon-beta

Biological

BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8

SCH 721015

Biological

Comparison of different doses and frequency of investigational agent

Other names: Adenoviral-mediated Interferon-beta, Ad.hIFN-beta

Primary outcomes

  1. To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and

    Time frame: Through Day 85

Secondary outcomes

  1. To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,

    Time frame: Through Day 85

  2. and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.

    Time frame: 15 years or until subject dies, whichever comes first

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Biogen
  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Mar 7, 2006
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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