View clinical trials related to Glioma.
Filter by:This study will examine the safety of a twice-a-day dosing regimen of the experimental drug Enzastaurin in patients with malignant glioma (a cancerous brain tumor) who are and who are not taking certain anti-seizure medicines. Enzastaurin may prevent the formation of new blood vessels that tumors need to grow. It has shown some effect against brain tumors in animals and in some patients with recurrent gliomas. This study will see if the drug can help patients with gliomas and how much drug they should be given. Patients 18 years of age and older with malignant glioma that has recurred after standard therapy may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, magnetic resonance imaging (MRI) or computed tomography (CT) scans, and an electrocardiogram. Participants are divided into two groups of patients-those who are and those who are not taking certain anti-seizure medications-in order to determine if the anti-seizure medication alters the way the body handles Enzastaurin. Patients in both groups are further divided into different dosing regimens: some in each group take Enzastaurin once a day for 3 weeks, followed by twice a day for 3 weeks; others in the group take the drug twice a day for 3 weeks followed by once a day for 3 weeks. The medication is taken by mouth every day. Treatment is given in 6-week cycles and may continue for 1 year unless the tumor grows or the patient develops unacceptable drug side effects. In addition to drug treatment, patients have the following tests and procedures: - Medical history, physical, and neurological examinations every 3 weeks during the first cycle and then every 6 weeks. - MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides into the cylindrical scanner. - Routine blood tests every week during the first cycle and every 3 weeks after that. - Electrocardiogram on days 21 and 42 of the first cycle, just before taking the drug and 30 minutes and 4 hours after taking the drug. - Pharmacokinetic studies within 3 days of day 21 of the first cycle. Several blood samples are drawn to measure levels of Enzastaurin. Patients taking the drug once a day have blood samples drawn before the morning dose and 1, 2, 4, 6 and 24 hours after the dose. Patients taking the drug twice a day have samples drawn before the morning dose, at 1, 2, 4, 6 and 12 hours after the dose, and then 12 hours after the evening dose. In addition, on day 1 an extra tube of blood is drawn at the time of the Enzastaurin dose and 4 hours later. - Dynamic MRI with spectroscopy or PET. These tests are done to help distinguish live tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done at the same time as the standard procedure. PET uses a radioactive substance to show cellular activity in specific tissues of the body. The patient is given an injection of a sugar solution in which a radioactive isotope has been attached to the sugar molecule. A special camera detects the radiation emitted by the radioisotope, and the resulting images show how much glucose is being used in various parts of the body. Because rapidly growing cells, such as tumors, take up and use more glucose than normal cells do, this test can be used to show active tumors.
It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors has not been evaluated in the pediatric population and the proper dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently with standard radiation therapy for diffuse pontine brainstem glioma.
This study will analyze tissue and blood samples from patients with gliomas (a type of brain tumor) to develop a new classification system for these tumors. Tumor classification can help guide treatment, in part by predicting how aggressive a tumor may be. Gliomas are currently classified according to their grade (how quickly they may grow) and the type of cells they are composed of. This system, however, is not always accurate, and sometimes two tumors that appear to be identical under the microscope will have very different growth patterns and responses to treatment. The new classification system is based on tumor genes and proteins, and may be used in the future to better predict a given tumor s behavior and response to therapy. Patients with evidence of a primary brain tumor and patients with a known glioma who will be undergoing surgery to remove the tumor may participate in this study. A sample of tumor tissue removed in the course of a participant s normal clinical care will be used in this study for laboratory analysis of genes and chromosome abnormalities. A small blood sample will also be collected for genetic analysis. In addition, clinical information on patients condition and response to treatment will be collected every 6 months over several years. This information will include findings from physical and neurologic examinations, radiographic findings, and response to therapy, including surgery, radiation and chemotherapy.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma.
RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with recurrent/progressive high grade gliomas.