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

Here is some free information on mesothelioma research from mesothelioma lawyers. Learn about the exclusion criteria 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.

Exclusion Criteria:
1. History of infection with Listeria, prior vaccination with a listeria-based vaccine, or a positive fecal culture of Listeria at screening
2. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
3. Allergy to penicillin or yeast or other component of the study drug product (e.g., glycerol)
4. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
5. Artificial (prosthetic) joint or other artificial implant or devices that cannot be easily removed
6. Known coagulation (blood clotting) disorder or recent thrombotic event
7. Certain types of blood transfusions within 14 days prior to receiving study drug or a condition requiring regular blood transfusions more than twice per month
8. Taking the following medications:
Anti-coagulation medications
Systemically active steroids for more than 2 days within 28 days prior to receiving study drug
More than 325 mg per day of aspirin
More than 2 g per day of acetaminophen
Systemic antibiotics within 14 days prior to receiving study drug
Another investigational product within 28 days prior to receiving study drug
9. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
10. Infection with HIV, hepatitis B or C, or HTLV-1 (human t-lymphotropic virus type 1) at screening
11. Pregnant or lactating, or close contact with pregnant women or newborn babies
12. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

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