Malignant Glioma Clinical Trial
Official title:
Phase I/II Study of LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma
The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has no yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
- Each treatment cycle lasts 28 days (four weeks). LBH589 is taken orally three times per
week (i.e. Monday-Wednesday-Friday or Tuesday-Thursday-Sunday) every other week. Since
we are looking for the highest dose of LBH589 that can be given safely to people who
are also taking bevacizumab, not everyone who participates in this study will receive
the same amount of the drug. The dose of LBH589 given will depend on the number of
participants who have been enrolled and how well they tolerated their doses. The dose
of bevacizumab will be the same for everyone.
- On days 1 and 15 of each cycle, bevacizumab will be given as an infusion intravenously
in the clinic.
- The following tests and procedures will be performed at time intervals specified in the
protocol: physical and neurological examination; assessments of the tumor by MRI or CT
scan; routine blood tests; routine urine tests; pregnancy test for women of child
bearing potential; research blood tests and an EKG.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02764151 -
First in Patient Study for PF-06840003 in Malignant Gliomas
|
Phase 1 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Completed |
NCT00953121 -
Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG)
|
Phase 2 | |
| Completed |
NCT00766467 -
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas
|
Phase 2 | |
| Active, not recruiting |
NCT03233204 -
Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
| Recruiting |
NCT05045027 -
Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma
|
Early Phase 1 | |
| Completed |
NCT02507583 -
Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma
|
Phase 1 | |
| Completed |
NCT04109209 -
Psychological Intervention For Brain Tumor Caregivers
|
N/A | |
| Recruiting |
NCT04937413 -
The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation
|
Early Phase 1 | |
| Completed |
NCT03615404 -
Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma
|
Phase 1 | |
| Active, not recruiting |
NCT04175301 -
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.
|
Phase 2 | |
| Terminated |
NCT02659800 -
Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
|
Phase 1 | |
| Active, not recruiting |
NCT02323880 -
Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
|
Phase 1 | |
| Completed |
NCT00782756 -
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
|
Phase 2 | |
| Terminated |
NCT02855086 -
Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
|
Phase 1/Phase 2 | |
| Completed |
NCT02861222 -
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
|
Phase 1 | |
| Completed |
NCT00634231 -
A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT01792505 -
Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
|
Phase 1 | |
| Completed |
NCT00190723 -
A Study of LY317615 in Patients With Brain Tumors
|
Phase 2 | |
| Recruiting |
NCT04323046 -
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
|
Phase 1 |