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

NCT03250520 | Completed Early Phase 1

• 1 other identifier: HIM 2017-072
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

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

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

  Preoperative and at 1.3, 6, 12, 18 and 24 months.

• Change in tumor size

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

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

Study Arms (2)

glioma brain stem

EXPERIMENTAL

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

high grade recurrent brain tumor in the central nervous system

EXPERIMENTAL

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

Interventions

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.

Also known as: Pt(acac)2/Titanium dioxide (Ti02), Pt(acac)2/F-TiO2, NPt, NPt-Ca

glioma brain stem; high grade recurrent brain tumor in the central nervous system

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Hospital Infantil de Mexico Federico Gomez

DF, Mexico

Location

MeSH Terms

Conditions

Brain Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in the Neurology Department

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: August 15, 2017
• Study Start: September 1, 2017
• Primary Completion: January 28, 2022
• Study Completion: June 28, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

ME (1)