AMG 102 and Avastin for Recurrent Malignant Glioma
Glioblastoma MultiformeGliosarcomaThe primary purpose of the study is to assess the response rate of AMG 102 and Avastin treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate overall survival and 6-month progression-free survival rates in this population and to assess the safety of this combination in this population. Patients must have recurrent histologically confirmed diagnosis of World Health Organization (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at Duke. In initial Phase I and II clinical trials, four potential Avastin-associated safety issues were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most common side effect for AMG 102 have been nausea and fatigue.
Tarceva/Rapamycin for Children With Low-grade Gliomas With or Without Neurofibromatosis Type 1 (NF1)...
Low-grade GliomasThis study will evaluate the feasibility of combining two drugs, Tarceva (an anti-EGFR agent), and Rapamycin (an mTOR inhibitor), in children with progressive low-grade gliomas who have failed initial conventional treatment. In addition to evaluating the toxicity of this drug regimen, the potential efficacy of the regimen will be assessed.
HLA-A2-Restricted Glioma Antigen-Peptides Vaccinations With Poly-ICLC for Recurrent WHO Grade II...
AstrocytomaOligoastrocytoma1 moreThis is a pilot vaccine study in adults with recurrent WHO Grade II gliomas. The purpose of this study is to test the safety and efficacy of an experimental tumor vaccine made from peptides in combination with the study drug Poly-ICLC. Poly-ICLC, manufactured by Oncovir, Inc., has already been received and is generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases. The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted.
Phase 2a Study of AdV-tk With Standard Radiation Therapy for Malignant Glioma (BrTK02)
Malignant GliomaGlioblastoma Multiforme1 moreThe purpose of this study was to evaluate the safety and potential efficacy of Gene Mediated Cytotoxic Immunotherapy for malignant gliomas. The approach used an adenoviral vector (disabled virus) engineered to express the Herpes thymidine kinase gene (aglatimagene besadenovec, AdV-tk), followed by an antiherpetic prodrug, valacyclovir. The AdV-tk vector was injected into the resection bed after standard tumor surgery and valacyclovir pills were taken for 14 days. Standard radiation and chemotherapy were administered which have been shown to work cooperatively with AdV-tk + prodrug to kill tumor cells. The hypothesis is that this combination therapy can be safely delivered and will lead to improvement in the clinical outcome for patients with newly diagnosed malignant gliomas, including glioblastoma multiforme (WHO grade IV) and anaplastic astrocytomas (WHO grade III).
Vaccine Therapy in Treating Patients With Malignant Glioma
Brain and Central Nervous System TumorsRATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma.
Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma
GlioblastomaGliosarcomaPrimary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of Zactima among MG pts on & not on enzyme inducing anti-epileptic drugs (EIAEDs) when combo w imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on & not on EIAEDs when combo w Zactima & hydroxyurea Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month progression free survival (PFS) rate & median PFS
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
GlioblastomaGliosarcoma1 moreObjectives: To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma To characterize any toxicity associated with the combination oral topotecan and Temodar. To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.
Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has...
Childhood High-grade Cerebellar AstrocytomaChildhood High-grade Cerebral Astrocytoma8 moreThis phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.
Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing...
GliomaThis research study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. This newly developed vaccine may stop cancer cells from growing.
Hypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant...
Brain CancerMALIGNANT GLIOMA6 moreThe best dose of radiation to be given with bevacizumab is currently unknown. This study will use higher doses of radiation with bevacizumab than have been used before. This study will test the safety of radiation given at different doses with bevacizumab to find out what effects, good and/or bad, it has on the patient and the malignant glioma or related brain cancers.