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NCT02359565 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma
A Phase 1 study of Malignant Glioma and Lynch Syndrome, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 12
- Study locations
NCT02359565 is a Phase 1 study of Malignant Glioma and Lynch Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 71 participants, below the 90-participant average among 40 other Malignant Glioma trials with a reported enrollment target (21% lower). The trial reports 12 study locations across 11 states.
The verdict
NCT02359565, a Phase 1 study of Malignant Glioma and Lynch Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 12
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of pembrolizumab and to see how well it works in treating younger patients with high-grade gliomas (brain tumors that are generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas (brain stem tumors), brain tumors with a high number of genetic mutations, ependymoma or medulloblastoma that have come back (recurrent), progressed, or have not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune system, and may interfere with the ability of tumor cells to grow and spread.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Diffusion Weighted Imaging
- PROCEDURE Conventional Magnetic Resonance Imaging
- PROCEDURE Diffusion Tensor Imaging
- PROCEDURE Dynamic Contrast-enhanced MR Perfusion
Study Locations (12)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta
Illinois
- Lurie Children's Hospital-Chicago - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-06-03 |
| Est. Completion | 2027-01-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02359565
The ClinicalTrials.gov registry entry for NCT02359565 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 40 other Malignant Glioma trials with a reported enrollment target (21% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Malignant Glioma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02359565 reports 12 study locations spanning 11 distinct geographic areas - top geographies include California, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02359565 about?
NCT02359565 is a clinical study titled "Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma". This phase I trial studies the side effects and best dose of pembrolizumab and to see how well it works in treating younger patients with high-grade gliomas (brain tumors that are generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas (brain stem tumors), brain tumo...
What is the current status of trial NCT02359565?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2015-06-03. Estimated completion is 2027-01-16.
What conditions does trial NCT02359565 study?
This clinical trial studies the following conditions: Malignant Glioma, Lynch Syndrome, Recurrent Medulloblastoma, Recurrent Brain Neoplasm, Recurrent Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT02359565?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Diffusion Weighted Imaging (PROCEDURE), Conventional Magnetic Resonance Imaging (PROCEDURE), Diffusion Tensor Imaging (PROCEDURE), Dynamic Contrast-enhanced MR Perfusion (PROCEDURE).
Who is sponsoring clinical trial NCT02359565?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02359565 being conducted?
This trial has 12 study locations across California, Colorado, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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