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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: Completed Early Phase 1 study of Diffuse Intrinsic Pontine Glioma, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigators will use liquid chromatography/tandem mass spectrometry (LC-MS/MS). An API 4000 instrument will be used, which has an approximate sensitivity of 0.1 ng/mg. Given the dimensions of the biopsy needle used, 10 mm length and 0.75 mm diameter, the investigators expect that each core will have an approximate volume of 4.5 mm2, which translates to a likely mass of 4.5 mg. Given that approximately 10 mg of tumor tissue has been necessary for quantification of gemcitabine and its matabo
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 |
What the finished NCT02992015 record still lists
NCT02992015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02992015's enrollment target sits among peer trials
2 29th of 28 the lowest of 28 other Diffuse Intrinsic Pontine Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Intrinsic Pontine Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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