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Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Single Arm Phase I/II study of intra-pleural HSV1716 administration.

HSV1716 Intra-pleural delivery

Penella J Woll, MB BS PhD FRCP

HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5.

Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant pleural mesothelioma forms plaques that are distributed on the surface of the pleural space in the lung. Approximately 30% of patients require an indwelling pleural catheter for drainage of pleural effusions. In this patient group, the indwelling catheter may be used to facilitate loco-regional delivery of HSV1716 to the pleural space.

This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.

The study will be conducted in two parts. PART A is a single centre, single dose design, open label. Patients with inoperable malignant pleural mesothelioma will receive a single dose of HSV1716 by intrapleural administration. Delivery will be by direct administration via an indwelling catheter into the pleural cavity. PART B is a single centre, repeat dose design, open label. Two groups of three patients with inoperable malignant pleural mesothelioma will receive 2 (group 1) or 4 (group 2) single doses of HSV1716 at weekly intervals. Administration will be via an indwelling catheter into the pleural cavity.

Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.

A Phase I/IIa Study of the Safety, Tolerability and Biological Effect of Single and Repeat Administration of the Selectively Replication-competent Herpes Simplex Virus HSV1716 Into the Tumor-bearing Pleural Cavity (Intrapleural) in Patients With Inoperable Malignant Pleural Mesothelioma.

Virttu Biologics Limited

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Symptoms and General Pathology

Sarcoma

Osteosarcoma

Wilms Tumor

Neuroblastoma

Sarcoma, Ewing

Rhabdomyosarcoma

Nerve Sheath Neoplasms

Neurofibrosarcoma

Chordoma

Neoplasms, Connective and Soft Tissue

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Peripheral Nervous System Diseases

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Neoplasms, Fibrous Tissue

Neurofibromatoses

Neurofibroma

Soft Tissue Sarcoma

Wilms' Tumor

Ewing Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Neuroepithelioma

Neurofibromatosis

Research participants with localized disease receiving HSV1716 as an intratumoral injection

Research participants with metastatic disease receiving HSV1716 intravenously

HSV1716

Timothy Cripe, M.D., PhD.

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

HSV1716 in Patients With Non-Central Nervous System (Non-CNS) Solid Tumors

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

Timothy Cripe

Prinicpal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.	NCT01721018	Malignant Pleur...	HSV1716 Intra-p...	18 Years -	Virttu Biologics Limited
HSV1716 in Patients With Non-Central Nervous System (Non-CNS) Solid Tumors	NCT00931931	Rhabdomyosarcom... Osteosarcoma Ewing Sarcoma Soft Tissue Sar... Neuroblastoma Wilms Tumor Malignant Perip... Clival Chordoma Non-CNS Solid T...	HSV1716	7 Years - 30 Years	Nationwide Children's Hospital
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.	NCT01721018	Malignant Pleur...	HSV1716 Intra-p...	18 Years -	Virttu Biologics Limited

Spots Global Cancer Trial Database for hsv1716

Every month we try and update this database with for hsv1716 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hsv1716

Every month we try and update this database with for hsv1716 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hsv1716 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.