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NCT ID: NCT01386450 Recruiting - Low Grade Glioma Clinical Trials

AZD6244 in Children With Low-Grade Gliomas

Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - AZD6244 is an experimental drug designed to prevent tumor growth and shrink existing tumors. It has been studied in adults with cancer, but it has not been studied in children with cancer. Researchers want to see if AZD6244 is a safe and effective treatment for older children and young adults who have gliomas (brain tumors) that have not responded to standard treatments. Objectives: - To test the safety and effectiveness of AZD6244 in older children and young adults who have gliomas that have not responded to standard treatments. Eligibility: - People between 12 and 21 years of age who have gliomas that have not responded to standard treatments. Design: - Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor imaging studies. Those in the study may also have their spinal fluid tested to see whether the cancer has spread to other parts of the nervous system. - Participants will take AZD6244 as a capsule. It must be swallowed whole on an empty stomach twice a day for 28 days. Those in the study will have up to 13 cycles (4 weeks each) of treatment (1 year). - Participants will keep a diary to record doses taken and any side effects of the treatment. - Participants will have frequent blood tests and imaging studies.

NCT ID: NCT01378481 Terminated - Adult Glioblastoma Clinical Trials

High-Dose Vorinostat and Fractionated Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Glioma

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This study is being done to determine if an investigational cancer treatment called vorinostat combined with fractionated stereotactic radiation therapy (FSRT) is effective in treating recurrent high grade gliomas. The main goal of this research study is to determine the highest dose of vorinostat that can be given to patients with recurrent tumors. The study will also determine the potential side effects and safety of these treatment combinations. Vorinostat is a small molecule inhibitor of histone deacetylase (HDAC). HDAC inhibitors help unravel the deoxyribonucleic acid (DNA) of the cancer cells and make them more susceptible to the treatment with radiation.

NCT ID: NCT01358058 Active, not recruiting - Low Grade Glioma Clinical Trials

Proton Radiation Therapy for Gliomas

Start date: May 2011
Phase: N/A
Study type: Interventional

In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy. In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.

NCT ID: NCT01351519 Terminated - Glioblastoma Clinical Trials

A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

Start date: May 2011
Phase: Phase 2
Study type: Interventional

In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

NCT ID: NCT01351337 Completed - Clinical trials for Glioma, Motor Pathway

Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area

Start date: October 2008
Phase: N/A
Study type: Interventional

Resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we used DTI-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional connections of the illustrated PT by direct electrical stimulation. We evaluated the reliability of DTI-based tractography for PT mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques.

NCT ID: NCT01339039 Terminated - Clinical trials for Anaplastic Oligodendroglioma (AO)

Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma

Start date: December 2011
Phase: Phase 1
Study type: Interventional

Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in patients with recurrent glioblastoma and has been studied extensively in other types of solid tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other cancers. Information from experiments in laboratories suggests that the combination of plerixafor and bevacizumab may help prevent the growth of gliomas. Part 1: The investigators are looking for the highest dose of plerixafor that can be given safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination. Part 2: The investigators are looking to see if plerixafor can get past the blood-brain barrier and into brain tumors. The investigators will also do blood tests to find out how the body uses and breaks down the drug combination. Part 3: The investigators are looking for for more information re: safety and tolerability of plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination.

NCT ID: NCT01338857 Terminated - Clinical trials for Recurrent or Progressive Low-grade Glioma

Sorafenib in Children and Young Adults With Recurrent or Progressive Low-Grade Astrocytomas

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if a drug called sorafenib can shrink LGA tumors (low-grade astrocytomas) in children and adults. Previous research has given us a better understanding of this type of tumor by studying the genetic "make-up" of LGAs. From this research, the investigators found that a drug called sorafenib may stop the growth of tumor cells by blocking some of the molecules needed for cell growth and by blocking blood flow to the tumor. This trial is studying how well sorafenib works in treating patients with LGAs, and how the effects relate to the specific genetic "make-up" of your particular tumor. This testing of your tumor's genetic make-up is optional and requires available tumor tissue for testing. In summary, the aims of this study are: To see if sorafenib can shrink LGAs; how well sorafenib is tolerated in patients with LGAs; and, how the effects of sorafenib relate to the genetic make-up of individual LGAs (Optional Study)

NCT ID: NCT01331135 Completed - Clinical trials for Renal Cell Carcinoma

Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors

Aflac ST0901
Start date: April 2011
Phase: Phase 1
Study type: Interventional

The best treatment for recurrent cancers or those that do not respond to therapies is not known. Typically, patients with these cancers receive a combination of cancer drugs (chemotherapy), surgery, or radiation therapy. These treatments can prolong their life but may not offer a long-term cure. This study proposes using a drug called Sirolimus in combination with common chemotherapy drugs to treat patients with recurrent and refractory solid tumors. Sirolimus has been found to inhibit cell growth and to have anti-tumor activity in pediatric solid tumors in previous studies and, therefore, has the potential to increase the effectiveness of the chemotherapy drugs when given together. This study wil investigate the highest dose of Sirolimus that can be given orally with other oral chemotherapy drugs. Cohorts of 2 subjects will be started at the minimum dose. The dose will be increased in the next 2 subjects as long as there were no major reactions in the previous groups. This study will also seek to learn more about the side effects of sirolimus when used in this combination and what effects the drug has on the white cells and the immune system. Successful use of this drug will impact the cancer population greatly by providing an increased chance of survival to those with resistant or recurrent cancers.

NCT ID: NCT01324635 Terminated - Brain Metastasis Clinical Trials

Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors

Start date: May 2012
Phase: Phase 1
Study type: Interventional

This is an open label phase I clinical trial with two arms, representing single and fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for 2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no intra-patient dose escalation. Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of 1st fraction of radiation. Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or tomotherapy technology.

NCT ID: NCT01316809 Completed - Clinical trials for Glioblastoma Multiforme

AZD8055 for Adults With Recurrent Gliomas

Start date: March 4, 2011
Phase: Phase 1
Study type: Interventional

Background: - AZD8055 is an experimental cancer treatment drug that works by inhibiting a protein called mTOR, which is known to promote tumor cell and blood vessel growth and to control tumor s energy and nutrient levels. AZD8055 is the first drug that inhibits both types of mTOR protein and is expected to be more effective than prior mTOR inhibitors. However, more research is needed to determine its safety and effectiveness in treating brain tumors known as gliomas that have not responded to standard treatments. Objectives: - To evaluate the safety and effectiveness of AZD8055 in individuals with gliomas that have not responded to standard treatments. Eligibility: - Individuals at least 18 years of age who have been diagnosed with gliomas that have not responded to standard chemotherapy, surgery, or radiation. Design: - Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. - Participants will be separated into two treatment groups: one group that will receive surgery to remove the glioma and one that will not have surgical treatment. - Participants in the nonsurgical treatment group will take AZD8055 by mouth daily for a 42-day cycle of treatment. Participants will keep a diary to record doses and keep track of any side effects. - Participants in the surgical treatment group will take AZD8055 by mouth daily for 7 days, and then will have tumor removal surgery. At least 3 weeks after surgery, participants will resume doses of AZD8055 and will continue to take the drug for as long as the tumor does not recur. - During treatment, participants will have regular visits to the clinical center, involving frequent blood and urine tests and other examinations to monitor the effects of treatment. Participants will have imaging studies to study the cancer's response to the treatment. - Participants will continue to have cycles of treatment for as long as the treatment continues to be effective and the side effects are not severe enough to stop participation in the study....