A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors or DIPG
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|ClinicalTrials.gov Identifier: NCT03330197|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : June 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Brain Tumor Diffuse Intrinsic Pontine Glioma||Biological: Ad-RTS-hIL-12 Drug: oral veledimex||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||There will be two groups of patients enrolled.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I 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|
|Actual Study Start Date :||September 26, 2017|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: Ad-RTS-hIL-12 +veledimex
Intratumoral Ad-RTS-hIL-12 injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors (supratentorial tumors and DIPG)
2.0 x 10^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12
Drug: oral veledimex
2 dose levels (10mg/day, 20mg/day) 14 (or 15) oral daily doses of veledimex
- The safety and tolerability of intratumoral Ad-RTS-hIL-12 and veledimex as measured by dose limiting toxicities and compliance. [ Time Frame: From Day 0 through 30 days after the last dose of veledimex ]
- To measure the veledimex in blood and brain tumor by using the LC-MS method [ Time Frame: From Day 0 through 30 days after the last dose of veledimex ]
- Evaluate preliminary efficacy of Ad-RTS-hIL-12 and veledimex by assessing survival and tumor response rates [ Time Frame: 2 Years ]
- Measure immune response of Ad-RTS-hIL-12 and veledimex by a quantitative multiplex immunoassay for determination of IL-12 and IFNg levels [ Time Frame: 28 Days ]
- Subjects with Ad-RTS-hIL-12 and veledimex related adverse events will be assessed for safety by CTCAE v4.0 [ Time Frame: 2 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330197
|United States, California|
|University of California San Francisco, Benioff Children's Hospital|
|San Francisco, California, United States, 94158|
|United States, Illinois|
|Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Dana- Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Study Director:||Arnold B Gelb, MD||ZIOPHARM Oncology, Inc.|