Zotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial...
Brain TumorAstrocytoma3 moreBackground: Zotiraciclib (TG02) is an investigational drug that penetrates the blood-brain barrier and might treat brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors. Objective: To find out if Zotiraciclib (TG02) is safe, and to find out if it in combination with TMZ is as effective as TMZ alone in people with brain tumors. Eligibility: People ages 18 and older with a brain tumor that has progressed after standard treatment Design: In phase I part, the Bayesian optimal interval (BOIN) design will be used to find the maximum tolerated dose (MTD) of Zotiraciclib (TG02) for Arm 1 (dose dense TMZ) and Arm 2 (metronomic TMZ) independently. Then a randomized cohort expansion compared progression free survival at 4 months (PFS4) of the two arms for an efficient determination of a TMZ schedule to combine with Zotiraciclib at MTD. In Phase II part, a Bayesian design based on posterior probability will be used to monitor efficacy. Participants will be screened with: Medical history Physical exam Blood and urine tests Magnetic resonance imaging (MRI) of the brain if they have not had one in 14 days Heart test Tissue sample from prior surgeries Participants will take Zotiraciclib (TG02) plus TMZ by mouth in 28-day cycles. Some will take TMZ for 7 days on and 7 days off. Others will take it every day. They will all take Zotiraciclib (TG02) three days before Cycle 1, and then on four days during every cycle. They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after each Zotiraciclib (TG02) dose. They will all keep a diary of when they take the drugs and their symptoms. Participants will have study visits. These include: Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests every 4 weeks Blood tests every 2 weeks Participants will continue treatment until their disease gets worse or they have intolerable side effects. Participants will also be enrolled in another protocol to test molecular markers for their brain tumor.
Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma...
GlioblastomaGrade IV Astrocytoma2 moreThis is a single-arm, open-label, multicenter study in approximately 52 adults with primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) after treatment(s) including surgery and radiotherapy with or without chemotherapy and following discontinuation of any previous standard or investigational lines of therapy.
Pegylated Interferon ALFA-2b in Children With Juvenile Pilocytic Astrocytomas and Optic Pathway...
Juvenile Pilocytic AstrocytomasOptic Pathway GliomasThis is a phase II study of the drug, pegylated interferon alfa-2b (PEG-Intron), used to treat brain tumors in a pediatric population. Researchers want to see if treatment with PEG-Intron will stop tumor growth for patients with juvenile pilocytic astrocytomas or optic pathway gliomas. The purposes of this study are: To learn more about the response to pegylated interferon To learn more about the side effects of pegylated interferon To learn more about MRI images in patients with Juvenile Pilocytic Astrocytomas or Optic Pathway Gliomas. To learn more about quality of life in patients treated with pegylated interferon
Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma...
GliomaGlioblastoma Multiforme1 moreHyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.
3T MRI Biomarkers of Glioma Treatment Response
Adult Anaplastic AstrocytomaAdult Anaplastic Ependymoma5 moreThis pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in measuring treatment response in patients with high-grade glioma. New diagnostic procedures, such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in measuring treatment response in patients receiving treatment for high-grade gliomas.
Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent...
Adult Anaplastic AstrocytomaAdult Anaplastic Oligodendroglioma5 moreThis partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.
Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade...
Adult Anaplastic AstrocytomaAdult Anaplastic Ependymoma12 moreThis phase I trial studies the side effects and best dose of alisertib when combined with fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the growth of tumor cells by blocking an enzyme needed for the cells to divide. Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic radiosurgery uses special positioning equipment to send a single high dose of radiation directly to the tumor and cause less damage to normal tissue. Delivering stereotactic radiosurgery over multiple doses (fractionation) may cause more damage to tumor tissue than normal tissue while maintaining the advantage of its accuracy.
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.
Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for...
Adult Anaplastic AstrocytomaAdult Anaplastic Ependymoma12 moreThis clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade...
GliomaGlioblastoma Multiforme1 moreThe pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma.