An Early Phase 1 interventional study of Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania in Brain Tumor, Pediatric, Brainstem Glioma and Brain Tumor, Pediatric, Recurrent, sponsored by Hospital Infantil de Mexico Federico Gomez. Completed at 1 site in Mexico. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Hospital Infantil de Mexico Federico Gomez · Early Phase 1, Interventional, and Supportive care
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.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Hospital Infantil de Mexico Federico Gomez is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania
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.
Also known as: Pt(acac)2/Titanium dioxide (Ti02), Pt(acac)2/F-TiO2, NPt, NPt-Ca
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©
Time frame: 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.
Time frame: Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.
Plan to share: Undecided
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Hospital Infantil de Mexico Federico Gomez