Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2006-03-31
2009-10-31
Brief Summary
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* 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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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose level 4
Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
SCH 721015
Comparison of different doses and frequency of investigational agent
Dose level 5
Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
SCH 721015
Comparison of different doses and frequency of investigational agent
Dose Level 1
on Days 1 and 15
SCH 721015
Comparison of different doses and frequency of investigational agent
Dose Level 2
On Days 1 and 15
SCH 721015
Comparison of different doses and frequency of investigational agent
Dose Level 3
On Days 1 and 15
SCH 721015
Comparison of different doses and frequency of investigational agent
Interventions
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Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
SCH 721015
Comparison of different doses and frequency of investigational agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Biogen
INDUSTRY
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Daniel H. Sterman, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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mesothelioma research foundation
Other Identifiers
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803776
Identifier Type: -
Identifier Source: org_study_id
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