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The INFINITE study is for patients with malignant pleural mesothelioma (MPM) whose previous treatment regimens have failed.
What is the purpose of the INFINITE study?
The purpose of the INFINITE clinical research study is to determine the safety and effectiveness of the investigational agent (rAd-IFN), when given with celecoxib and gemcitabine, on slowing or stopping tumor growth.
How long does study participation last?
If you qualify and decide to participate in the INFINITE study, your participation will continue indefinitely, depending on how well you tolerate the study treatment. You will receive study treatment until your disease progresses.
What will happen during the study?
During the study, you will participate in 3 study periods:
- Screening Period – lasts up to 28 days
- Treatment Period – duration depends on how well you tolerate the study treatment
- Long-Term Follow-Up Period –study site will contact you every 3 months (indefinitely) to determine the status of your disease. Follow-up visits may be performed face-to-face, by study doctor contact, or by telephone
For the Treatment Period, you will have a 1 in 2 chance of being randomly assigned to the treatment group or the control group.
| TREATMENT GROUP |
CONTROL GROUP |
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Receives one dose of the investigational agent
rAd-IFN by infusion into the lining of your affected lung on Day 1.
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Does not receive the investigational agent
rAd-IFN.
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Receives celecoxib by mouth twice daily for 14
days (study Day 1 to 14).
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Receives celecoxib by mouth twice daily for 14
days (study Day 1 to 14).
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Receives gemcitabine through a vein (typically
in your arm) on Days 1 and 8 of a repeating 3-week cycle until your disease
progresses or you withdraw from the study.
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Receives gemcitabine through a vein (typically
in your arm) on Days 1 and 8 of a repeating 3-week cycle until your disease
progresses or you withdraw from the study.
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DO I QUALIIFY?
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