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Investigator(s):
Raffit Hassan, M.D. Principal Investigator Phone: 301-451-8742
Referral Contact(s):
Yvonne Mallory, R.N., B.S.N. Research Nurse Phone: 301-402-0255 malloryy@mail.nih.gov	Jeannette Nashed, C.R.N.P. Nurse Practitioner Phone: 301-594-1827 Jeannette.nashed@nih.gov

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Key Eligibility Criteria:

• Histologically confirmed epithelial or biphasic malignant pleural mesothelioma (MPM) not amenable to potentially curative surgical resection (biphasic tumors that have a predominantly [≥ 50 percent] sarcomatoid component will be excluded)
• No prior systemic chemotherapy for MPM
• Measurable disease
• ≥ 18 years of age
• ECOG ≤ 1
• Adequate hematologic, renal, and hepatic function
• Willing and able to take folic acid, cyanocobalamin (vitamin B12), and dexamethasone
• No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
• Not pregnant or breast feeding

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Study Outline:

• Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
• Eligible participants will receive two IV infusions of CRS-207 (administered through a vein) two weeks apart, followed two weeks later by up to six cycles of pemetrexed and cisplatin
• Three weeks after completion of chemotherapy, participants will receive an additional two doses of CRS-207 three weeks apart
• Participants who are clinically stable may continue to receive additional CRS-207 infusions every 16 weeks
• Follow-up visits every 8 weeks until disease progression

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/11/12
Updated: 11/5/12