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| Sponsor: | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Collaborator: |
FDA Office of Orphan Products Development |
| Information provided by (Responsible Party): | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00931931 |
Purpose
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 105 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 106 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 virus injection. Participates who experience at least stable disease or relapse following a determination of stable disease, may qualify for subsequent injections in PART 2. PART 2 requires signing of a separate consent.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-CNS Solid Tumors |
Biological: HSV1716 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalation Study of Intratumoral Herpes Simplex Virus-1 Mutant HSV1716 in Patients With Refractory Non-Central Nervous System (Non-CNS) Solid Tumors |
| Estimated Enrollment: | 18 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 7 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kristina Kruskamp | 513-636-5336 | cancer@cchmc.org |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: James Geller, M.D. 513-636-6312 james.geller@cchmc.org | |
| Principal Investigator: James Geller, M.D. | |
| Study Director: | Timothy Cripe, M.D., PhD. | Nationwide Children's Hospital |
More Information
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00931931 History of Changes |
| Other Study ID Numbers: | 2009-0075 |
| Study First Received: | May 28, 2009 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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Neoplasms |