Mesothelioma Related Clinical Trials:
A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Beta (BG00001, Ad.hIFN-β for Pleural Malignancies

In Page Navigation: - General Info - Purpose - Eligibility - Contacts & Locations - Additional Information

   

Status: Recruiting
Sponsors and Collaborators: University of Pennsylvania; Biogen Idec
Information provided by: University of Pennsylvania
Government Identifier: NCT00299962

Condition: Pleural Mesothelioma; Metastatic Pleural Effusions
Intervention: Gene Transfer: BG00001 (adenoviral-mediated interferon-beta)

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Purpose:


This Phase I study will evaluate the safety of two doses of BG00001. 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, on Day 1 and Day 15. BG00001 is given through a catheter in the pleural space.

Study Type:   Interventional
Study Design:   Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:   A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Beta (BG00001, Ad.hIFN-β for Pleural Malignancies

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • - 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).

Secondary Outcome Measures:
  • - 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.

Estimated Enrollment:   15
Study Start Date:   March 2006
Estimated Study Completion Date:   March 2008

Detailed Description:

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.

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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • pathologically documented malignant pleural effusion from malignant mesothelioma or, metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
  • must have evaluable disease
  • must have ECOG performance status of 0 or 1
  • 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

Exclusion Criteria:

  • malignant pleural effusions secondary to lymphoma
  • rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
  • presence of known untreated brain metastases
  • use of concurrent systemic steroids or immunosuppressants

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299962

Contacts
Contact: Adri Recio, RN     215-573-6760     arecio@mail.med.upenn.edu    
Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania     Recruiting
      Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators
University of Pennsylvania
Biogen Idec

Investigators
Principal Investigator:     Daniel H. Sterman, M.D.     University of Pennsylvania    

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Additional Information:

Study ID Numbers:   803776, UPCC 03505
First Received:   March 3, 2006
Last Updated:   March 3, 2006
ClinicalTrials.gov Identifier:   NCT00299962
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
gene therapy  
immunotherapy  

Study placed in the following topic categories:
Pleural Effusion
Pleural Diseases
Interferons
Benfluorex
Interferon-beta
Mesothelioma
Interferon Alfa-2b
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Respiratory Tract Diseases
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions

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