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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

Primary Purpose

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

Status
Completed
Phase
Early Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania
Sponsored by
Hospital Infantil de Mexico Federico Gomez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor, Pediatric, Brainstem Glioma

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Infantil de Mexico Federico Gomez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

glioma brain stem

high grade recurrent brain tumor in the central nervous system

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 10, 2017
Last Updated
February 27, 2023
Sponsor
Hospital Infantil de Mexico Federico Gomez
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1. Study Identification

Unique Protocol Identification Number
NCT03250520
Brief Title
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
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infantil de Mexico Federico Gomez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Pediatric, Brainstem Glioma, Brain Tumor, Pediatric, Recurrent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glioma brain stem
Arm Type
Experimental
Arm Title
high grade recurrent brain tumor in the central nervous system
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania
Other Intervention Name(s)
Pt(acac)2/Titanium dioxide (Ti02), Pt(acac)2/F-TiO2, NPt, NPt-Ca
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the quality of life using the PedsQL Cancer Module©
Description
Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module©
Time Frame
Preoperative and at 1.3, 6, 12, 18 and 24 months.
Title
Change in tumor size
Description
Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance.
Time Frame
Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
DF
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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