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Gene Therapy for Pleural Malignancies

Brief 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.

Tracking Information
First Received DateMarch 3, 2006
Last Changed DateFebruary 21, 2017
Start DateMarch 2006
Anticipated Primary Completion DateApril 2023
Primary Outcome Measures

To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and [Time Frame: Through Day 85]

Secondary Outcome Measures

To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation, [Time Frame: Through Day 85]

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]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Pleural Mesothelioma
  • Metastatic Pleural Effusions
Intervention
  • Biological: Adenoviral-mediated Interferon-beta
  • Biological: SCH 721015
Study Arms / Comparison Groups5 / 0
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.

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

Recruitment Information
Recruitment StatusActive, not recruiting
Anticipated Enrollment18
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT00299962
Responsible Party,
SponsorUniversity of Pennsylvania
Verification DateFebruary 2017
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