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