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

February 27, 2023 updated by: Daniel Eduardo Alvarez Amado, Hospital Infantil de Mexico Federico Gomez

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • DF, Mexico
        • Hospital Infantil de Mexico Federico Gomez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: glioma brain stem
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.
Other Names:
  • Pt(acac)2/Titanium dioxide (Ti02)
  • Pt(acac)2/F-TiO2
  • NPt
  • NPt-Ca
Experimental: high grade recurrent brain tumor in the central nervous system
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.
Other Names:
  • Pt(acac)2/Titanium dioxide (Ti02)
  • Pt(acac)2/F-TiO2
  • NPt
  • NPt-Ca

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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©
Preoperative and at 1.3, 6, 12, 18 and 24 months.
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.
Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil de Mexico Federico Gomez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

January 28, 2022

Study Completion (Actual)

June 28, 2022

Study Registration Dates

First Submitted

June 10, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIM 2017-072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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