Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma

Status Active, not recruiting

Clinical Trial Summary

Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive childhood brain tumor that, despite many past clinical trials, has never been shown to respond to chemotherapy. Radiation therapy (RT) is effective in extending life but is not curative; median overall survival is 11 months. It is still unclear why the hundreds of clinical trials involving chemotherapy of DIPG have failed to demonstrate any activity against the tumor. Given that many agents tried in clinical trials cross the blood brain barrier (BBB), it is possible that there are factors specific to DIPG and its location that prevent adequate drug penetration. Gemcitabine has been selected for this study because there is strong evidence of DIPG cell line inhibition in vitro and good BBB penetration. Furthermore, pediatric dosing and toxicity has been established in prior studies of children with relapsed solid tumors and leukemia. The primary aim of this study is to determine the presence of gemcitabine in childhood DIPG tissue after systemic treatment with the drug. The secondary aim is to quantify the intratumoral gemcitabine concentration after systemic treatment. Participants in this study will be given a one time IV dose of gemcitabine prior to having standard of care surgery. During surgery biopsies will be obtained for clinical and research purposes along with a blood sample. Because patients will be undergoing this biopsy as part of their standard of care therapy here at Children's Hospital Colorado, this is an optimal time to obtain a tumor biopsy for this study. The biopsy will serve to see if the study drug is penetrating the tumor. Patients will then enter a follow-up period for 30 days post surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02992015
Study type	Interventional
Source	University of Colorado, Denver
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	September 23, 2016
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01922076` - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas	Phase 1
Recruiting	`NCT05476939` - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0	Phase 3
Terminated	`NCT03330197` - A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG	Phase 1/Phase 2
Terminated	`NCT03690869` - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma	Phase 1/Phase 2
Terminated	`NCT01182350` - Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)	Phase 2
Recruiting	`NCT04837547` - PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy	Phase 1
Active, not recruiting	`NCT04911621` - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma	Phase 1/Phase 2
Not yet recruiting	`NCT06333899` - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion	Early Phase 1
Completed	`NCT00879437` - Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma	Phase 2
Active, not recruiting	`NCT02420613` - Vorinostat and Temsirolimus With or Without Radiation Therapy in Treating Younger Patients With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma	Phase 1
Completed	`NCT03086616` - CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009)	Phase 1
Recruiting	`NCT01837862` - A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas	Phase 1/Phase 2
Not yet recruiting	`NCT06093165` - RE-irradiation of Diffuse MIdline Glioma paTients	N/A
Withdrawn	`NCT03632317` - A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas	Phase 2
Completed	`NCT02502708` - Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors	Phase 1
Recruiting	`NCT02233049` - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication	Phase 2
Completed	`NCT00996723` - Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)	Phase 1
Recruiting	`NCT05009992` - Combination Therapy for the Treatment of Diffuse Midline Gliomas	Phase 2
Recruiting	`NCT04049669` - Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG	Phase 2
Recruiting	`NCT05298995` - GD2-CAR T Cells for Pediatric Brain Tumours	Phase 1