Brain Cancer Clinical Trial
Official title:
A Phase II Single Arm Trial of Palonosetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma (MG) Patients Receiving Irinotecan in Combination With Bevacizumab
1. Primary Objective:
- To determine the efficacy and tolerability of palonosetron and dexamethasone in
preventing acute CINV in brain tumor patients during the first 24 hours of
receiving Irinotecan /Bevacizumab regimens.
2. Secondary Objective
- To determine the safety and tolerability of palonosetron in brain tumor patients.
- To determine the effects of glucocorticoid and anticonvulsants on the efficacy of
palonosetron.
- To determine the efficacy of palonosetron and dexamethasone in preventing delayed
CINV in brain tumor patients during days 2-5.
- To determine if patients receiving palonosetron have less fatigue than baseline.
Before the patients receive the palonosetron, a physical exam and blood tests are performed
to determine eligibility. If eligible and willing, subjects are given Palonosetron
intravenously. Subjects are given the Palonosetron and Dexamethasone 30 minutes before the
first dose of Irinotecan and Bevacizumab chemotherapy. The total expected duration of
participation is 57 days. Subjects are also asked to complete 4 questionnaires about nausea
and vomiting, as well as daily functioning and fatigue. Subjects are asked to complete these
questionnaires before starting chemotherapy, the day of starting chemotherapy and for the
next 4 days after receiving chemotherapy, for a total of 6 times. Subjects are asked to
complete this set of questionnaires each of the 3 times that they receive chemotherapy
during the 6-week treatment cycle.
The other treatments subjects would normally receive for their brain tumor and their routine
care are not affected by the study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05023434 -
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
|
||
| Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT04114786 -
3D Printed Mask for GBM and Brain Mets
|
N/A | |
| Recruiting |
NCT04367779 -
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
|
||
| Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
| Completed |
NCT02911155 -
Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
|
||
| Completed |
NCT02852655 -
A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma
|
Phase 1 | |
| Completed |
NCT00329589 -
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
|
Phase 1 | |
| Completed |
NCT01650922 -
Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples
|
N/A | |
| Completed |
NCT00505141 -
Urban Environmental Exposures and Childhood Cancer
|
N/A | |
| Completed |
NCT00504660 -
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
|
Phase 2 | |
| Completed |
NCT00979810 -
Image-Guided Stereotactic Biopsy of High Grade Gliomas
|
N/A | |
| Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
| Active, not recruiting |
NCT02851706 -
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
|
||
| Completed |
NCT02798406 -
Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects
|
Phase 2 | |
| Completed |
NCT01012609 -
External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas
|
Phase 2 | |
| Completed |
NCT00782756 -
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
|
Phase 2 | |
| Terminated |
NCT03149575 -
VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM
|
Phase 3 | |
| Completed |
NCT01974804 -
Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
|
||
| Withdrawn |
NCT01320787 -
18-F-Fluoroacetate as PET Imaging Agent
|
Phase 1 |