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

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.

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Key information

Conditions

Brain Tumor, Pediatric, Brainstem Glioma Brain Diseases Brain Neoplasms Brain Tumor, Pediatric, Recurrent Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospital Infantil de Mexico Federico Gomez

DF, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histopathological diagnosis or MRI of the brain stem or tumor of recurrent high-grade glioma.
Indication of palliative surgical treatment by neurosurgery.
Good general condition, enabling the realization of surgical treatment.
Scale Lansky > 20)
conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not applicable to the patient.

Exclusion criteria

Patients with emerging infectious diseases or fever in the last 72 hours prior to placement of the NPt-Ca.
Patients whose parents/carers do not authorize expressly the realization of procedure with knowledge of its experimental nature, are not agreed or established their commitment to meet follow-up parameters established by this Protocol.
Patients with surgical complications prior to placement of the NPt-Ca.
Patients in which the size and location of the lesion do not allow their surgical approach or an increase in volume by infiltration of the lesion with 3 ml of volume of NPt-Ca.
Patient whose neurological condition do not allow the implementation of MRI without anesthesia.

Treatment and study plan

Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania

Drug

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.

Other names: Pt(acac)2/Titanium dioxide (Ti02), Pt(acac)2/F-TiO2, NPt, NPt-Ca

Primary outcomes

Change in the quality of life using the PedsQL Cancer Module©

Time frame: Preoperative and at 1.3, 6, 12, 18 and 24 months.

Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module©
Change in tumor size

Time frame: Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.

Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance.

Sponsors and collaborators

Lead sponsor

Hospital Infantil de Mexico Federico Gomez

Other

Registry information

Official study title

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)

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Aug 15, 2017
Registry last updated: Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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