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Glioma clinical trials

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NCT ID: NCT00576446 Completed - Malignant Glioma Clinical Trials

Surgical Resection With Gliadel Wafer Followed by Dendritic Cells Vaccination for Malignant Glioma Patients

Gliadel Wafer
Start date: April 2007
Phase: Phase 1
Study type: Interventional

Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 12 months, with 90 - 95% of patients surviving less than 2 years. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially prolonged survival and even the few treatment options shown to exhibit small increases in survival primarily benefit certain (i.e., young) patient subpopulations. Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body to recognize the tumor cells as foreign and produce its own response to fight off recurring tumor cells. A promising means of causing an immune response so the body can create this immunity is through the use of dendritic cell (DC) vaccines. Dendritic cells are a small group of cells contained in everyone's white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria, or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system. gliadel is an FDA - approved drug - a wafer containing a concentrated amount of a chemotherapy agent. These wafers are placed into the brain cavity after the tumor is resected (removed) and deliver a steady amount of immediate chemotherapy medicine to the surrounding brain tissue. Also, since Gliadel is a local chemotherapy, it will prevent the detrimental suppression (weakening) of the immune system shown with systemic (throughout the body) chemotherapy. In prior Phase l and phase ll studies, patients who received chemotherapy following Dendritic cells demonstrated longer progression free and overall survival than the patients who received Dendritic cells or chemotherapy alone. The purpose of this study is to determine whether after standard therapy of tumor resection surgery, along with placement of Gliadel wafers at time of surgery followed by dendritic cell vaccines will not only generate (start) an immune response, but will provide longer progression free survival. Patients who were screened and not enrolled in this clinical trial due to screen failure will be notified of the reason for screen failure. Pre HIV counseling and appropriate referral resources will be provided. If the screen failure is due to the positive HIV test, appropriate post HIV counseling will be provided and appropriate referrals will be made. The charts of the patients with screen failures will be destroyed.The patients charts who will be enrolled in the study kept in the locked cabinet in the research office. patients will be assigned a unique identifying code known only to the research team. Data will be captured by various source documents, or, as necessary, abstracted from hospital medical records by an experienced registered nurse. The electronic data for viral testing will be accessible to research personnel only.

NCT ID: NCT00561873 Completed - High Grade Glioma Clinical Trials

Nimotuzumab in Children With HGG

Start date: June 2004
Phase: N/A
Study type: Observational

Determination of efficiency of nimotuzumab in children with high grade glioma.

NCT ID: NCT00561691 Completed - Clinical trials for Diffuse Instrinsic Ponitine Glioma

Nimotuzumab in Children With Intrinsic Pontine Glioma

Start date: April 2006
Phase: N/A
Study type: Observational

Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.

NCT ID: NCT00540176 Completed - Clinical trials for Malignant Gliomas, Glioblastoma Multiforme

The Safety and Efficacy of DCA for the Treatment of Brain Cancer

Start date: October 2007
Phase: Phase 2
Study type: Interventional

Malignant gliomas, which include Glioblastoma multiforme (GBM), are the most common and most aggressive types of brain cancer, accounting for approximately 60% of primary brain tumors. These tumors are characterized by diverse molecular abnormalities (within the same tumor), which, along with the difficulties of many standard chemotherapies crossing the blood barrier, contribute to the very poor response to therapy and poor survival. We recently showed that Dichloroacetate (DCA, an inhibitor of the mitochondrial pyruvate dehydrogenase kinase) was able to depolarize cancer (but not normal) mitochondria and induce apoptosis in cancer but not normal tissues. We believe that altering the metabolism of cancers like glioblastoma (DCA switches metabolism from the cytoplasmic glycolysis to the mitochondrial glucose oxidation) we inhibit the resistance to apoptosis that characterizes cancer. Because metabolism (i.e. glycolysis) is the end result of many and diverse molecular pathways, the effects of DCA might be positive in cancers with diverse molecular backgrounds. DCA is also a very small molecule that readily crosses the blood brain barrier. Therefore we hypothesize that DCA will be an effective and relative non-toxic potential therapy for malignant gliomas. We are conducting a phase II trial with 2 parallel arms: a) patients with newly diagnosed malignant gliomas and b) patients with recurrent gliomas or gliomas that have failed standard therapy (which includes surgery, radiotherapy and chemotherapy). All patients need to have a histological diagnosis. DCA will be given orally and patients will be followed for a minimum of 6 months. The tumor size will be followed by standard MRI or CT criteria and glucose uptake (a direct effect of DCA on the tumor) will be measured by FDG-PET imaging. Several clinical parameters and quality of life will be followed. Potential toxicity (particularly peripheral neuropathy) will be closely followed and dose-de-escalation protocols are in place in case of toxicity. In addition, escape protocols for the application of standard therapy (when appropriate) are in place in patients with no evidence of response to DCA. In vitro studies will be performed in the tissues obtained at the time of surgery (where appropriate) and correlated prospectively with clinical data. There is limited ability to accept patients outside of Alberta; this is in part because the visit and testing schedule is intense, requiring residence in Edmonton for at least 6 months.

NCT ID: NCT00539344 Completed - Clinical trials for Recurrent or Progressive Malignant Glioma

A Phase 1, Open-Label, Dose Escalation Study of ANG1005 in Patients With Malignant Glioma

Start date: October 2007
Phase: Phase 1
Study type: Interventional

This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the safety, tolerability, and PK of ANG1005 in patients with recurrent or progressive malignant glioma. ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle). Each patient will participate in only 1 dose group and will receive up to 6 cycles of treatment provided there is no evidence of tumor progression, there is recovery to ≤Grade 1 or baseline nonhematologic, ANG1005-related toxicity (except alopecia), the absolute neutrophil count is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.

NCT ID: NCT00532948 Completed - Glioma Clinical Trials

A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas

Start date: May 2007
Phase: Phase 1
Study type: Interventional

This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.

NCT ID: NCT00528684 Completed - Malignant Glioma Clinical Trials

Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas

Start date: July 2006
Phase: Phase 1
Study type: Interventional

RATIONALE: Oncolytic viruses such as reovirus (REOLYSIN®) can specifically kill tumor cells while leaving healthy cells unharmed. PURPOSE: This phase I/II study investigates the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and anti-tumor effect of intralesional administration of REOLYSIN® therapeutic reovirus in patients with malignant glioma with evaluable disease which is progressive/recurrent despite surgery and/or radiotherapy with or without chemotherapy. (The phase I portion of the study is currently enrolling patients.)

NCT ID: NCT00526812 Completed - Glioma Clinical Trials

A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas

Start date: November 30, 2005
Phase: Phase 1
Study type: Interventional

This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.

NCT ID: NCT00509431 Completed - Clinical trials for Brain and Central Nervous System Tumors

Erlotinib and Sirolimus in Treating Patients With Recurrent Malignant Glioma

Start date: August 2006
Phase: Phase 1
Study type: Interventional

RATIONALE: Erlotinib and sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with sirolimus and to see how well they work in treating patients with recurrent malignant glioma.

NCT ID: NCT00504660 Completed - Clinical trials for Glioblastoma Multiforme

6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients

Start date: September 2003
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if the combination of 6-Thioguanine, Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or glioblastoma multiforme in patients who have failed previous treatments. The safety of these combination treatment will also be studied. Objectives: 1.1 To determine the efficacy, as measured by 12 month progression-free survival, of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in the treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma multiforme. 1.2 To determine the long-term toxicity of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in recurrent anaplastic glioma or glioblastoma multiforme patients treated in this manner. 1.3 To determine the clinical relevance of genetic subtyping tumors as a predictor of response to this chemotherapy and long term survival