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Oncolytic HSV-1716 in Treating Younger Patients With Refractory or Recurrent High Grade Glioma That Can Be Removed By Surgery | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Oncolytic HSV-1716 in Treating Younger Patients With Refractory or Recurrent High Grade Glioma That Can Be Removed By Surgery

A Phase I Study of Intratumoral/Peritumoral Herpes Simplex Virus-1 Mutant HSV1716 in Patients With Refractory or Recurrent High Grade Gliomas (HGG)

NCT02031965•Pediatric Brain Tumor Consortium

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and the safety of injecting HSV1716 (a new experimental therapy) into or near the tumor resection cavity. The injection will be done at the time of surgery. HSV1716 is a virus that has a gene which has been changed or removed (mutated) in such a way that lets the virus multiply in dividing cells of the tumor and kills the tumor cells.

Detailed Description

PRIMARY OBJECTIVES: I. To determine whether intratumoral/peritumoral injection of HSV1716 (oncolytic HSV-1716) is safe in children with recurrent high-grade gliomas amenable to resection. II. To estimate the maximum tolerated dose (MTD) or a recommended Phase II dose of intratumoral/peritumoral injection of HSV1716. III. To describe any dose-limiting toxicities (DLT) of intratumoral/peritumoral injection of HSV1716 at the doses given to children with high-grade gliomas. IV. To evaluate changes in tumor enhancement, quantitative magnetic resonance (MR) measures of tumor perfusion (relative cerebral blood volume \[rCBV\], transfer coefficient \[k\^trans\], fractional blood-plasma volume \[Vp\] and extravascular extracellular space per unit volume tissue \[Ve\] values and apparent diffusion coefficient \[ADC\]) in response to HSV1716 injection. SECONDARY OBJECTIVES: I. To measure antiviral immune response in patients with refractory high-grade gliomas injected with HSV1716. II. To measure the systemic viremia and viral shedding following intratumoral/peritumoral administration of HSV1716. III. To preliminarily describe the antitumor activity of HSV1716 injection within the confines of a Phase I study. IV. To evaluate anti-tumor immune cellular and humoral immune responses. V. To evaluate changes in fluorodeoxyglucose (FDG)- positron emission tomography (PET) uptake in response to HSV1716 injection. VI. To evaluate changes in tumor choline values using magnetic resonance (MR) spectroscopy in response to HSV1716 injection and further delineate from progressive disease versus pseudo-progression post therapy. OUTLINE: This is a dose-escalation study. Patients receive oncolytic HSV-1716 intratumorally (IT) and peritumorally after undergoing surgical tumor resection. Patients also receive dexamethasone intravenously (IV) prior to and 6 and 12 hours after surgery. After completion of study treatment, patients are followed up every 2 months for 1 year, every 6 months for 4 years, and then annually for 10 years.

Eligibility

Age

12 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration; all other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration; in the event that the patient's condition deteriorates (performance score \< 60) within 48 hours prior to the injection the patient is no longer eligible to receive HSV1716 injection
•* An intraoperative MRI upon resection will confirm the distance of the planned injection sites from the ventricular system prior to the HSV1716 injection; intra-operatively, the neurosurgeon may decide to not inject the HSV1716 or may revise the sites of HSV1716 injection if injection cannot be guaranteed \>= 1 cm from the ventricular system; patient will removed from the study if there are not sufficient areas in the tumor cavity to guarantee injection of HSV1716 \>= 1 cm from the ventricular system
•Patients must have received prior therapy other than surgery and must have fully recovered from the acute treatment related toxicities of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
•Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration treatment or at least six (6) weeks if nitrosourea
•Investigational/Biologic agent:
•* Biologic or investigational agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent \>= 7 days prior to study registration
•* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
•* Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration; Note: A list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates
•Patients must have had their last fraction of:
•* Craniospinal irradiation (\> 24 Gray \[Gy\]) or total body irradiation \> 3 months prior to registration
+25 more criteria

Exclusion Criteria

•Patients must be those for whom surgical resection is clinically indicated; the intent of surgical resection may include debulking or attempt to resect as much of the tumor as safely feasible; if a gross total or near total resection is not feasible, HSV1716 injection into the wall of the resection cavity, encompassing residual tumor, is permissible
•* Patients must be amenable to receiving 1 dose of HSV1716 intra-operatively with planned HSV1716 injection sites \>= 1 cm from the ventricular system AND meet at least one of the criteria below based upon pre-surgical magnetic resonance imaging (MRI):
•* Tumor is \>= 1 cm from the ventricular system
•Patients with metastatic disease i.e. leptomeninges, multi-focal lesions in the CNS
•Patients whose tumor lies within 1 cm of the ventricular system
•Patients who are receiving any other investigational agents
•Patients who are currently receiving other anti-cancer agents are excluded from this trial
•Patients with history of prior HSV encephalitis or encephalitis due to other etiologies
•There is no available information regarding human fetal or teratogenic toxicities
•Pregnant women are excluded to avoid the risk of systemic intrauterine/neonatal HSV infection
+5 more criteria

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

December 1, 2013

Primary Completion Date

May 1, 2016

Completion Date

May 1, 2016

Last Updated

May 30, 2016

Enrollment

ACTUAL participants

Conditions

Recurrent Childhood Anaplastic AstrocytomaRecurrent Childhood Anaplastic OligoastrocytomaRecurrent Childhood Anaplastic OligodendrogliomaRecurrent Childhood Giant Cell GlioblastomaRecurrent Childhood GlioblastomaRecurrent Childhood Gliomatosis CerebriRecurrent Childhood Gliosarcoma

Interventions

oncolytic HSV-1716

BIOLOGICAL

dexamethasone

DRUG

therapeutic conventional surgery

PROCEDURE

laboratory biomarker analysis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Oncolytic HSV-1716 in Treating Younger Patients With Refractory or Recurrent High Grade Glioma That Can Be Removed By Surgery

Inclusion Criteria

Exclusion Criteria

Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors

18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas

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