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NCT00716469 · ClinicalTrials.gov registry record · Phase 1
Phase I Clinical Study of the Safety of Photodynamic Therapy (PDT) Using LS11 in Children With Plexiform Neurofibromas
A Phase 1 study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00716469 is a Phase 1 study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 7 participants.
The verdict
NCT00716469, a Phase 1 study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Plexiform neurofibromas (PN) represent one of the most significant complications of NF1. They are a significant cause of morbidity in neurofibromatosis type 1 (NF1) by causing pain, impaired function, and disfigurement. They may become life-threatening through mechanical compression of vital organs such as the trachea, great vessels, or spinal cord, and may significantly interfere with normal function when located in the extremities or orbit. The only effective therapy for PN is total surgical excision. However, due to local infiltration of normal tissue, gross total resection is usually not feasible, and often PN are completely unresectable due to their location, size, and multiplicity. To date, other therapeutic modalities, including radiotherapy and chemotherapy, have not shown efficacy in PN. In the present study, local photodynamic therapy will be investigated. Photodynamic therapy (PDT) utilizes a drug, called a photosensitizer or photosensitizing agent, and a particular type of light. When photosensitizers are exposed to a specific wavelength of light, they produce a form of oxygen that kills nearby cells. PDT is expected to result in treatment response with shrinkage of tumor. The main purpose of the study is to determine the maximum amount of light that can be safely used with LS11 for PDT in children with plexiform neurofibromas.
Interventions
- DRUG LS11
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00716469
The ClinicalTrials.gov registry entry for NCT00716469 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LS11 is the first listed.
NCT00716469 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00716469 about?
NCT00716469 is a clinical study titled "Phase I Clinical Study of the Safety of Photodynamic Therapy (PDT) Using LS11 in Children With Plexiform Neurofibromas". Plexiform neurofibromas (PN) represent one of the most significant complications of NF1. They are a significant cause of morbidity in neurofibromatosis type 1 (NF1) by causing pain, impaired function, and disfigurement. They may become life-threatening through mechanical compression of vital organs ...
What is the current status of trial NCT00716469?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2008-07. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00716469?
The interventions under investigation include: LS11 (DRUG).
Who is sponsoring clinical trial NCT00716469?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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