| Critètes d'exclusion |
- Prior therapy with Bev.
- Any anti-neoplastic therapy, including RT, for first relapse or recurrence.
- Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of metastatic disease extracranially.
- Evidence of impending herniation on imaging.
- Patients with infections that have required treatment with systemic antibiotics within 7 days of first dose of protocol therapy.
- The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone or in comparable doses with other glucocorticoids.
- Treatment with any investigational agents within 5 half-lives of the agent in question or, if the half life is unknown, within 28 days of enrollment.
- Pregnant or lactating females.
- Prior history of malignancy within 3 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of <0.01 ng/mL.
- Patients with active autoimmune diseases within 2 years of enrollment into the study including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, myasthenia gravis, Graves' disease, or uveitis except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an autoimmune condition has been clinically silent for 12 months or greater, the patient may be eligible for enrollment.
- Patients on immunosuppressive therapies; the use of topical, inhalational, ophthalmologic or intra articular glucocorticoids, or the use of physiologic replacement doses of glucocorticoids are permitted.
- Patients with primary immunodeficiency diseases.
- Patients with significant bleeding in the preceding 6 months or with known coagulopathies.
- History of abdominal fistula, intestinal perforation, or intra-abdominal abscess in the preceding 12 months.
- Known history of human immunodeficiency virus (HIV) infection, active hepatitis B, or untreated hepatitis C; patients who have completed a course of anti-viral treatment for hepatitis C are eligible.
- Significant cardiovascular disease, including New York Hospital Association Class III or IV congestive heart failure, myocardial infarction within 6 months of enrollment, unstable angina, poorly controlled cardiac arrhythmias, or stroke within the preceding 6 months.
- Any other uncontrolled inter current medical condition, including systemic fungal, bacterial, or viral infection; uncontrolled hypertension; diabetes mellitus; or chronic obstructive pulmonary disease requiring 2 or more hospitalizations in the preceding 12 months.
- Known sensitivity to Bev or any of the components of DSP-7888 Dosing Emulsion.
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HOPITAL FLEURIMONT
Groupe d'étude en oncologie du Québec