Clinical Trials for Mesothelioma Patients—A Study of Safety and Tolerability of Intravenous CRS-207: Outcome Measures

Read about the outcome measures for a current clinical trial about the safety and tolerability of intravenous CRS-207 in patients with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Official Title:
A Phase 1, Open-Label, Dose-Escalation, Multiple Dose Study of the Safety, Tolerability, and Immune Response of CRS-207 in Adult Subjects With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment

Primary Outcome Measures:
Dose-limiting toxicities related to the investigational agent [ Time Frame: 28 days after first dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Arms and Assigned Interventions:
CRS-207: Experimental
Biological: CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin
2-hour IV infusion once every 21 days, up to 4 doses. Doses from 1x10^8 cfu to 1x10^10 cfu.

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