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NCT00931931 · ClinicalTrials.gov registry record · Phase 1
HSV1716 in Patients With Non-Central Nervous System (Non-CNS) Solid Tumors
A Phase 1 study of Neuroblastoma and Soft Tissue Sarcoma, sponsored by Timothy Cripe.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00931931: Completed Phase 1 study of Neuroblastoma and Soft Tissue Sarcoma, sponsored by Timothy Cripe.
NCT00931931 is a Phase 1 study of Neuroblastoma and Soft Tissue Sarcoma that has completed, run by Timothy Cripe. The registered enrollment target is 18 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931931, a Phase 1 study of Neuroblastoma and Soft Tissue Sarcoma, has completed, sponsored by Timothy Cripe.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with relapsed solid tumors such as sarcomas and neuroblastoma have a poor survival, generally \< 20%. There is an urgent need for new treatments that are safe and effective. HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5, a specific determinant of virulence. Mutants lacking the RL1 gene are capable of replication in actively dividing cells but not in terminally differentiated cells - a phenotype exploited to selectively kill tumor cells. In previous clinical studies, HSV1716 has been shown to be safe when injected at doses up to 10\^5 plaque forming units (pfu) directly into human high-grade glioma and into normal brain adjacent to tumour, following excision of high-grade glioma. In an extension study, HSV1716 has been shown to be safe when injected at a dose of up to 10\^6 pfu directly into brain tumours. Replication of HSV1716 in human glioblastoma in situ has been demonstrated. Following a single administration of HSV1716 by direct injection into active recurrent tumor or brain adjacent to tumor, some patients have lived longer than might have been expected. This study seeks to evaluate the safety of a single injection of HSV1716 in the treatment of extracranial solid tumors in adolescents and young adults. HSV1716 has also proved safe when given by direct intra-tumoural injection in patients with squamous carcinoma of the head and neck, and in patients with malignant melanoma. Replication of HSV mutants in human sarcomas and neuroblastoma in cultured cells and human xenograft models has been demonstrated. This study is designed in two parts. PART 1 of the study specifies a single dose of virus. Participants who experience at least stable disease or relapse following a determination of stable disease, may qualify for subsequent doses in PART 2. PART 2 requires signing of a separate consent. Funding Source - FDA OOPD
Conditions Studied
Interventions
- BIOLOGICAL HSV1716
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-03 |
| Est. Completion | 2018-03-19 |
| Phase | Phase 1 |
What the finished NCT00931931 record still lists
NCT00931931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower).
The record links to 9 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which HSV1716 is the first listed.
NCT00931931 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00931931 about?
NCT00931931 is a clinical study titled "HSV1716 in Patients With Non-Central Nervous System (Non-CNS) Solid Tumors". Patients with relapsed solid tumors such as sarcomas and neuroblastoma have a poor survival, generally \< 20%. There is an urgent need for new treatments that are safe and effective. HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes th...
What is the current status of trial NCT00931931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-03. Estimated completion is 2018-03-19.
What conditions does trial NCT00931931 study?
This clinical trial studies the following conditions: Neuroblastoma, Soft Tissue Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Ewing Sarcoma.
What interventions are being tested in trial NCT00931931?
The interventions under investigation include: HSV1716 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00931931?
This trial is sponsored by Timothy Cripe, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00931931 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00931931's enrollment target sits among peer trials
18 77th of 94 higher than 14 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma 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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