Mesothelioma Clinical Trial
Official title:
A Pilot And Feasibility Trial Evaluating Two Different Chemotherapy Regimens In Combination With Intrapleural Adenoviral-Mediated Interferon-Alpha Gene Transfer For Malignant Pleural Mesothelioma
The purpose of this study is to find the safety of combination gene therapy and chemotherapy in patients with malignant pleural mesothelioma. Pleural catheter will be placed first, then pts will receive 2 doses of intrapleural vector followed by front line or second line chemotherapy 4-6 cycles every 21 days.
Malignant pleural mesothelioma (MPM) is a cancer for which there is no cure. The most
effective combination chemotherapy, Pemetrexed (Alimta)/Cisplatin, has yielded overall
response rates of up to 40%, but with improvements in overall median survival of only 3.5
months. Prior Phase I trials of intrapleural infusion (IP) of Ad.hIFN-beta (BG00001) were
safe. The most recent trial of IP Ad.IFNalpha (SCH 721015) at a dose of 3e11 viral particles
(vp) given three days apart was safe and well tolerated, and showed high levels of IFN in
pleural fluid and serum. Our preclinical data modeling this proposed study suggest that two
IP doses of Ad.IFN-alpha in combination with chemotherapy are well tolerated and markedly
enhances efficacy. The purpose of the new study is to determine the safety of administrating
intrapleural SCH 721015 (Ad.hIFN-alpha 2b) in combination with chemotherapy for the
management of malignant pleural mesothelioma. This study will enroll subjects with pleural
mesothelioma. Subjects will receive two fixed dosed of SCH 721015 followed by 4-6 cycles of
chemotherapy. Subjects will require placement of a pleural catheter for administration of SCH
721015.
Some patients require a pleural catheter for control of pleural fluid while some will have it
placed for research purpose only. Protocol participation is up to 15 years.
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