a phase ii study to treat advanced malignant glioma

Conditions: Advanced Malignant Glioma

Summary: the purpose of this study is to evaluate the effectiveness and safety of amg 102 for the treatment of advanced malignant glioma.


Eligibility criteria:
inclusion criteria: * subjects with documented histologically confirmed primary grade 4 advanced malignant glioma * no more than 3 prior relapses or prior systemic treatments * recurrent disease documented by mri after prior therapy * must have at least one site of bidimensionally measurable disease: * archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment * age ≥ 18 years * karnofsky performance score ≥ 60% * hemoglobin ≥ 10 g/dl * absolute neutrophil count ≥ 1.5 x 10(9th)/l * platelet count ≥ 100 x 10(9th)/l * serum creatinine ≤ 1.5 times upper limit of normal * alanine aminotransferase ≤ 2.5 times upper limit of normal * serum total bilirubin ≤ 2.5 times upper limit of normal * before any study-specific procedure, the appropriate written informed consent must be obtained exclusion criteria: * history of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) within 6 months before enrollment * evidence of acute intracranial/intratumoral hemorrhage; except for subjects with stable grade 1 hemorrhage * received radiation therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such therapy * treated previously with any c-met or hgf targeted therapy * treated with thalidomide or tamoxifen within 1 week before enrollment or has not recovered from the toxic effects of such cancer therapy * treated with immunotherapeutic agents, vaccines or mab therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such cancer therapy * treated with alkylating agents within 4 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy * treated with chemotherapy (non-alkylating agents) within 2 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy * surgical resection of brain tumor within 4 weeks before enrollment or have not recovered from acute side effects of such therapy, except for neurological effects * plans to receive surgery, radiation therapy or other elective surgeries during the course of the study * concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study * active infection within 7 days before enrollment * past or current history of another neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative or adjuvant treatment administered for the last 3 years * documented history of human immunodeficiency virus * documented history of chronic viral hepatitis * concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except: * use of low molecular weight heparins (lmwh, e.g., enoxaparin sodium \[lovenox\] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed * use of low dose warfarin (\< 2 mg/day) for prophylaxis against central venous catheter thrombosis is allowed * currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapeutic study(s) * had major surgery within 4 weeks before enrollment or recovering from prior surgery * known allergy or sensitivity to any of the excipients in the investigational product * pregnant or breast feeding * unwilling to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product, for: * male subjects * female subjects who are not post-menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this exclusion * previously treated with amg 102 * previously enrolled into this study * will not be available for follow-up assessment * has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures

Keywords: glioma brain tumor