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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

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ClinicalTrials.gov Identifier: NCT03250520
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Eduardo Alvarez Amado, Hospital Infantil de Mexico Federico Gomez

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.

Condition or disease Intervention/treatment Phase
Brain Tumor, Pediatric, Brainstem Glioma Brain Tumor, Pediatric, Recurrent Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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©

  2. 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.



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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250520


Locations
Mexico
Hospital Infantil de Mexico Federico Gomez
DF, Mexico
Sponsors and Collaborators
Hospital Infantil de Mexico Federico Gomez

Responsible Party: Daniel Eduardo Alvarez Amado, Researcher in the Neurology Department, Hospital Infantil de Mexico Federico Gomez
ClinicalTrials.gov Identifier: NCT03250520     History of Changes
Other Study ID Numbers: HIM 2017-072
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Titanium dioxide
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents