Overview

HSV G207 With a Single Radiation Dose in Children With Recurrent High-Grade Glioma

Status:
Not yet recruiting
Trial end date:
2025-10-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a clinical trial to assess the efficacy and confirm the safety of intratumoral inoculation of G207 (an experimental virus therapy) combined with a single 5 Gy dose of radiation in recurrent/progressive pediatric high-grade gliomas
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
Treovir, LLC
Criteria
Inclusion Criteria:

Patients meeting the following inclusion criteria will be eligible for the study:

- Age ≥ 3 years of age and ≤ 21 years of age at the time of study enrollment

- Patients must have a pathologically proven malignant high-grade glioma (including
glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, midline
diffuse glioma) which is progressive or recurrent despite standard care including
surgery, radiotherapy, and/or chemotherapy

- Lesion must be ≥ 1.0 cm and ≤ 4.0 cm in longest dimension and surgically accessible as
determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 4.0 cm
after debulking

- Multifocal disease on the unilateral side is eligible if at least one catheter can be
placed in all multifocal areas

- Performance score ≥ 60% (Karnofsky for children ≥16 years old; modified Lansky for
children < 16 years old)

- Patients with neurological deficits should have deficits that are stable for ≥ 1 week
prior to enrollment. A baseline detailed neurological exam should clearly document the
neurological status of the patient at the time of enrollment on the study

- Prior therapy: patients must have recovered from acute treatment related toxicities of
all prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy,
biologic therapy, or virotherapy prior to entering this study

- Myelosuppressive chemotherapy: patients must have received their last dose at least 3
weeks prior and demonstrated count recovery as defined below

- Investigational/Biologic agents: patients must have recovered from any acute
toxicities potentially related to the agent and received the last dose ≥ 7 days prior
to entering this study (this period must be extended beyond the time during which
adverse events are known to occur for agents with known adverse events ≥ 7 days). For
viral therapy or cellular therapy, patients must have received therapy ≥ 3 months
prior to study entry and have recovered from all acute toxicities potentially related
to the agent.

- Monoclonal antibodies: patient must have received last dose ≥ 28 days prior

- Radiation: Patients must have received their last fraction of radiation (≥ 54 Gy) ≥ 3
months prior to study entry. Patients must have received local palliative radiation ≥
28 days prior to study entry

- Patient must have adequate organ and marrow function as defined by the following:
Hemoglobin ≥8 g/dL (may receive blood transfusions); absolute neutrophil count ≥ 1.0 x
10^9 cells/L; platelet count ≥ 100 x 10^9 cells/L (transfusion independent defined as
not receiving platelets transfusions ≥ 7 days prior to enrollment); alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the
institutional upper limit of normal for age; creatinine within normal institutional
limits OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine
levels above institutional normal

- Written informed consent in accordance with institutional and FDA guidelines must be
obtained from patient or legal guardian

Exclusion Criteria:

Patients with the following conditions will be excluded from participation in the study:

- Primary cerebellar, brainstem or spinal tumors

- Metastatic disease or gliomatosis cerebri

- Acute infection or medical condition precluding surgery

- Pregnant or lactating

- Diagnosis of encephalitis or central nervous system (CNS) infection < 3 months prior,
or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis

- Tumor involvement which would require ventricular, cerebellar or brainstem inoculation
or would require access through a ventricle in order to deliver treatment

- Required steroid increase within 1 week prior to G207 inoculation or patients
requiring >4 mg of dexamethasone daily

- Known HIV seropositivity

- Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir,
penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any immunosuppressive
drug therapy (except dexamethasone or prednisone).

- Other current malignancy

- Concurrent anticancer or investigational drug