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Gene Therapy for Pleural Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Biogen Idec
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00299962
First received: March 3, 2006
Last updated: September 29, 2010
Last verified: September 2010
History of Changes

March 3, 2006
September 29, 2010
March 2006
April 2023   (final data collection date for primary outcome measure)
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and [ Time Frame: Through Day 85 ] [ Designated as safety issue: Yes ]
  • - To determine the MTD/MED and toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β).
  • - To analyze Ad.hIFN-β gene transfer with two doses (via pleural fluid ELISA for IFN-β).
Complete list of historical versions of study NCT00299962 on ClinicalTrials.gov Archive Site
  • To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation, [ Time Frame: Through Day 85 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • - To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation.
  • - To assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.
Not Provided
Not Provided
 
Gene Therapy for Pleural Malignancies
A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β 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.

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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pleural Mesothelioma
  • Metastatic Pleural Effusions
  • Biological: Adenoviral-mediated Interferon-beta
    BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
    Other Name: adenoviral-mediated Interferon-beta
  • Biological: SCH 721015
    Comparison of different doses and frequency of investigational agent
    Other Names:
    • Adenoviral-mediated Interferon-beta
    • Ad.hIFN-beta
  • Experimental: Dose level 4
    Interventions:
    • Biological: Adenoviral-mediated Interferon-beta
    • Biological: SCH 721015
  • Experimental: Dose level 5
    Interventions:
    • Biological: Adenoviral-mediated Interferon-beta
    • Biological: SCH 721015
  • Experimental: Dose Level 1
    on Days 1 and 15
    Intervention: Biological: SCH 721015
  • Experimental: Dose Level 2
    On Days 1 and 15
    Intervention: Biological: SCH 721015
  • Experimental: Dose Level 3
    On Days 1 and 15
    Intervention: Biological: SCH 721015
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
April 2023
April 2023   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00299962
803776, P01CA066726
No
Daniel H. Sterman, M.D., University of Pennsylvania
University of Pennsylvania
  • National Cancer Institute (NCI)
  • Biogen Idec
Principal Investigator: Daniel H. Sterman, M.D. University of Pennsylvania
University of Pennsylvania
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP