Metastatic Pleural Effusions, Pleural Mesothelioma
Conditions
Keywords
gene therapy, immunotherapy
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.
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
Interventions
BIOLOGICALAdenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
BIOLOGICALSCH 721015
Comparison of different doses and frequency of investigational agent
Sponsors
National Cancer Institute (NCI)
Biogen
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and | Through Day 85 |
Secondary
| Measure | Time frame |
|---|---|
| To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation, | Through Day 85 |
| and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival. | 15 years or until subject dies, whichever comes first |
Countries
United States
Outcome results
None listed