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NCT00716469: PDT
Phase I Clinical Study of the Safety of Photodynamic Therapy (PDT) Using Intratumoral Delivery of Non-coherent Light for Photoactivation of LS11 in Children With Plexiform Neurofibromas
Phase 1 trial testing LS11 in Neurofibroma in 7 participants. Terminated before completion.
1 July 2012
Quick facts
| Lead sponsor | Children's Hospital of Philadelphia |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 1 July 2008 |
| Primary completion | 1 July 2012 |
| Estimated completion | 1 July 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- LS11 — full drug profile →
Conditions studied
- Neurofibroma — all drugs for Neurofibroma →
Sponsor
Children's Hospital of Philadelphia
Who can join
Adults 3 to 21, any sex, with Neurofibroma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To determine the safety and tolerability of photodynamic therapy (PDT) for the treatment of plexiform neurofibromas in children.
Time frame: Week 4 and 12
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00716469
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neurofibroma
Currently open trials in the same condition.
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- NCT05199376 — Evaluation of Percutaneous Cryotherapy in the Treatment of Plexiform Neurofibromas and Unresectable Neurofibromas in Neu · NA · recruiting
- NCT03820778 — Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1 · NA · active not recruiting
- NCT00924196 — Natural History Study of Patients With Neurofibromatosis Type I · active not recruiting
Other Children's Hospital of Philadelphia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00716469 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Philadelphia
- Last refreshed: 14 April 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00716469.
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