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

Hospital Infantil de Mexico Federico Gomez

Status and phase

Completed

Early Phase 1

Conditions

Brain Tumor, Pediatric, Brainstem Glioma

Brain Tumor, Pediatric, Recurrent

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03250520

HIM 2017-072

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

5 to 14 years old

Volunteers

No Healthy Volunteers

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.