NCT03250520

Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca

Pilot Study of the Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial Platinum Acetylacetonate (1% wt) Supported by Sol-gel Technology Functionalized Titania (NPt-Ca)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hospital Infantil de Mexico Federico Gomez · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This Protocol is a pilot, clinical interventional study to selected patients between five and fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade recurrent in the central nervous system tumors, in whom there has been no response to conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow treatment with conventional measures, and that already have an indication for a neurosurgical palliative procedure. It will be a close pharmacovigilance on possible adverse effects related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.

Conditions

• Brain Tumor, Pediatric, Brainstem Glioma
• Brain Tumor, Pediatric, Recurrent

Interventions

Type	Name	Description
DRUG	Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania	Sol-gel process Pt(acac)2- F-TiO2 nanostructured material with antitumoral activity used as an alternative in the treatment of cancer tumors. The biocatalysts were prepared by the sol-gel route using the complex Pt(acac)2.

Timeline

• Start date: 2017-09-01
• Primary completion: 2022-01-28
• Completion: 2022-06-28
• First posted: 2017-08-15
• Last updated: 2023-02-28

Locations

1 site across 1 country: Mexico