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NCT02992015 · ClinicalTrials.gov registry record · Early Phase 1
Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma
A Early Phase 1 study of Diffuse Intrinsic Pontine Glioma, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT02992015 is a Early Phase 1 study of Diffuse Intrinsic Pontine Glioma that has completed, run by University of Colorado, Denver. The registered enrollment target is 2 participants, below the 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02992015, a Early Phase 1 study of Diffuse Intrinsic Pontine Glioma, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive childhood brain tumor that, despite many past clinical trials, has never been shown to respond to chemotherapy. Radiation therapy (RT) is effective in extending life but is not curative; median overall survival is 11 months. It is still unclear why the hundreds of clinical trials involving chemotherapy of DIPG have failed to demonstrate any activity against the tumor. Given that many agents tried in clinical trials cross the blood brain barrier (BBB), it is possible that there are factors specific to DIPG and its location that prevent adequate drug penetration. Gemcitabine has been selected for this study because there is strong evidence of DIPG cell line inhibition in vitro and good BBB penetration. Furthermore, pediatric dosing and toxicity has been established in prior studies of children with relapsed solid tumors and leukemia. The primary aim of this study is to determine the presence of gemcitabine in childhood DIPG tissue after systemic treatment with the drug. The secondary aim is to quantify the intratumoral gemcitabine concentration after systemic treatment. Participants in this study will be given a one time IV dose of gemcitabine prior to having standard of care surgery. During surgery biopsies will be obtained for clinical and research purposes along with a blood sample. Because patients will be undergoing this biopsy as part of their standard of care therapy here at Children's Hospital Colorado, this is an optimal time to obtain a tumor biopsy for this study. The biopsy will serve to see if the study drug is penetrating the tumor. Patients will then enter a follow-up period for 30 days post surgery.
Conditions Studied
Interventions
- DRUG Gemcitabine
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-09-23 |
| Est. Completion | 2024-03-06 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02992015
The ClinicalTrials.gov registry entry for NCT02992015 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (99% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 1 intervention - of which Gemcitabine is the first listed.
NCT02992015 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT02992015 about?
NCT02992015 is a clinical study titled "Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma". Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive childhood brain tumor that, despite many past clinical trials, has never been shown to respond to chemotherapy. Radiation therapy (RT) is effective in extending life but is not curative; median overall survival is 11 months. It is still unclea...
What is the current status of trial NCT02992015?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2016-09-23. Estimated completion is 2024-03-06.
What conditions does trial NCT02992015 study?
This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT02992015?
The interventions under investigation include: Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT02992015?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02992015 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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