Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

Status Recruiting

Clinical Trial Summary

The primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients. The intra-arterial chemotherapy at the ophthalmic artery is an important treatment option for retinoblastoma. However, the cardio-respiratory side effects (sudden onset of bradycardia, hypotension, a severe decrease in the compliance of lung, hypoxia) occasionally occurs during catheter manipulation in the ophthalmic artery. One of the purported mechanisms of cardio-respiratory side effects is vagal activation from the activation of trigeminal ganglion by afferent signals from the ophthalmic artery. Additionally, the chemotherapy agent can cause intra-arterial retinal precipitates. Therefore, it is expected that the dilation of the retinal artery may reduce the cardio-respiratory side effects and intra-arterial retinal precipitates. The hypothesis of this study is that the intravenously infused nitroglycerin will increase the compliance of the ophthalmic and retinal artery and decrease vagal stimulation and cardio-respiratory side effects during catheter manipulation and chemotherapy agent infusion. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of intravenously infused nitroglycerin and saline on the incidence of the cardio-respiratory side effect in pediatric retinoblastoma patients undergoing intra-arterial chemotherapy. Prior to the procedure, each patient will be randomized into either the control-first arm, saline, or study-first arm, nitroglycerin.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Retinoblastoma

Clinical Trial Details

NCT number	NCT04564521
Study type	Interventional
Source	Seoul National University Hospital
Contact	Young-Eun Jang, MD
Phone	82-2-2072-3664
Email	na0ag2@hotmail.com
Status	Recruiting
Phase	N/A
Start date	September 28, 2020
Completion date	December 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02933333` - G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor	Phase 4
Withdrawn	`NCT01151748` - Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma	Phase 2
Completed	`NCT01048892` - Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features	Phase 1
Active, not recruiting	`NCT00360750` - Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye	N/A
Completed	`NCT00003173` - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors	Phase 2
Enrolling by invitation	`NCT06227962` - Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors
Completed	`NCT01661400` - Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors	Phase 1
Terminated	`NCT02617862` - PCI Imaging System in Pediatric Ophthalmology	N/A
Recruiting	`NCT02329002` - SPT Screening in Irradiated Hereditary Retinoblastoma Survivors	N/A
Terminated	`NCT01466855` - A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma	Early Phase 1
Completed	`NCT01505569` - Auto Transplant for High Risk or Relapsed Solid or CNS Tumors	N/A
Completed	`NCT00002515` - Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer	Phase 2
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Completed	`NCT06367569` - Evaluation of MRI of the Pineal Gland in Retinoblastoma
Completed	`NCT02193724` - Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma
Completed	`NCT01884194` - Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging	N/A
Terminated	`NCT01393769` - Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage	Phase 2
Completed	`NCT00006246` - Busulfan in Treating Children and Adolescents With Refractory CNS Cancer	Phase 1
Terminated	`NCT00003926` - Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	Phase 1
Completed	`NCT00004006` - Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma	Phase 2