Neuroblastoma Clinical Trial
Official title:
A Phase I Dose Escalation Study of Intratumoral or Intravenous Herpes Simplex Virus-1 Mutant HSV1716 in Patients With Refractory 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 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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00492167 -
Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma
|
Phase 1 | |
| Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03107988 -
NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
|
Phase 1 | |
| Recruiting |
NCT04253015 -
A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
|
||
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03273712 -
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
|
Phase 2 | |
| Recruiting |
NCT02933333 -
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
|
Phase 4 | |
| Recruiting |
NCT00588068 -
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
|
||
| Recruiting |
NCT04301843 -
Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
|
Phase 2 | |
| Completed |
NCT00026780 -
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
|
||
| Recruiting |
NCT04040088 -
An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors
|
Early Phase 1 | |
| Recruiting |
NCT06057948 -
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
|
Phase 2 | |
| Not yet recruiting |
NCT06335745 -
PediCARE Health Equity Intervention in High-Risk Neuroblastoma
|
N/A | |
| Recruiting |
NCT02559778 -
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
|
Phase 2 | |
| Completed |
NCT02441062 -
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02245997 -
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
|
N/A | |
| Not yet recruiting |
NCT01156350 -
Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT01192555 -
Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01222780 -
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
|
Phase 1 |