Malignant Glioma Clinical Trial
Official title:
A Phase I/II Study of High-dose L-methylfolate in With Combination Temozolomide and Bevacizumab in Recurrent High Grade Glioma.
This is a Phase I/II non-randomized prospective study of high-dose L-methylfolate in combination with bevacizumab and temozolomide in patients with recurrent high-grade glioma. The primary objective of this phase II trial is to determine whether the addition of high-dose L-methylfolate to bevacizumab and temozolomide therapy improves progression-free survival (PFS) compared to previously reported results.
The phase I part of the study will be completed to determine the Maximum Tolerated Dose (MTD) of high-dose L-methylfolate in combination with bevacizumab at 10mg/kg IV every 14 days, a 5-day regimen per month of temozolomide at 150 mg/m2/day and a 250 mg tablet of vitamin C. Dose escalation will involve 3 patients treated at each dose level of L-methylfolate (15mg, 30 mg, 60 mg or 90 mg), and the MTD will be confirmed by expansion of 3 additional patients. It is anticipated that 6 to 15 patients will be enrolled in the phase 1 part of the study. Patients will continue treatment until disease progression. Once the MTD of L-methylfolate has been determined, patients enrolled at a lower dose level may increase L-methylfolate dose to the MTD dose, per investigator discretion. The phase II part of the study will consist of patients taking the MTD of L-methylfolate daily in combination with bevacizumab at 10 mg/kg IV every 14 days, a 5-day regimen per month of temozolomide at 150 mg/m2/day and a 250 mg tablet of vitamin C. There will be 32 patients treated in the Phase II study and the patients will continue treatment until progression. The 6 patients treated at the MTD cohort in Phase ;
| 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 |
NCT00634231 -
A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT02861222 -
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
|
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 |