Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Diffuse Intrinsic Pontine Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Supratentorial Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Stem Neoplasms

Infratentorial Neoplasms

Brain Tumor, Childhood

Anaplastic Astrocytoma

Neuroepithelioma

Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors.

Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG.

2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12

Ad-RTS-hIL-12

1 dose level (10mg/day) 15 oral daily doses of veledimex

Oral Veledimex - Arm 1 (Pediatric Brain Tumor)

2 dose levels (10mg/day, 20mg/day) 14 oral daily doses of veledimex

Oral Veledimex - Arm 2 (DIPG)

Jill Buck

This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor.

The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex in the pediatric population.

Eligible patients will be stratified to one of two arms, according to clinical indication for tumor resection. Pediatric patients who are scheduled for craniotomy and tumor resection will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12 will be administered by free-hand injection. Patients will continue on oral veledimex for 14 days. This arm has been completed and is currently closed to enrollment.

Pediatric patients with diffuse intrinsic pontine glioma (DIPG) will receive Ad-RTS-hIL-12 by stereotactic injection and then will continue on oral veledimex for 14 days.

The study is divided into three periods: the screening period, the treatment period and the follow-up period.

A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG

A Phase I/II Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Pediatric Brain Tumor Subjects

Alaunos Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG	NCT03330197	Pediatric Brain... Diffuse Intrins...	Ad-RTS-hIL-12 Oral Veledimex ... Oral Veledimex ...	0 Years - 21 Years	Alaunos Therapeutics
A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG	NCT03330197	Pediatric Brain... Diffuse Intrins...	Ad-RTS-hIL-12 Oral Veledimex ... Oral Veledimex ...	0 Years - 21 Years	Alaunos Therapeutics

Spots Global Cancer Trial Database for high grade glioma (hgg) not otherwise specified (nos)