HSV G207 Alone or With a Single Radiation Dose in Children With Progressive or Recurrent Supratentorial Brain Tumors

Completed · Phase 1

Conditions studied: Supratentorial Neoplasms, Malignant, Malignant Glioma, Glioblastoma, Anaplastic Astrocytoma, PNET, Cerebral Primitive Neuroectodermal Tumor, Embryonal Tumor

In brief

This study is a clinical trial to determine the safety of injecting G207 (a new experimental virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication and tumor cell killing, will also be tested.

Key facts

Study ID

NCT02457845

Run by

Gregory K. Friedman, MD

People needed

13

Starts

2016-05-01

Expected to finish

2024-01-01

Last updated by the study team

2024-01-19

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 36 months and < 19 years
• Pathologically proven malignant supratentorial brain tumor (including glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid/rhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and/or chemotherapy. A pathologically proven secondary malignant tumor without curative treatment options is eligible.
• Lesion must be > 1.0 cm in diameter and surgically accessible as determined by MRI
• Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study.
• Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)
• Investigational/Biologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received 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, patients must have received viral 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 ≥ 21 days prior
• Radiation: Patients must have received their last fraction of craniospinal radiation (>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation > 28 days prior to study entry.
• Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to study entry.
• Normal hematological, renal and liver function (Absolute neutrophil count > 1000/mm3, Platelets > 100,000/mm3, Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) < 1.3 x control, Creatinine within normal institutional limits OR > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, Total Bilirubin < 1.5 mg/dl, Transaminases < 3 times above the upper limits of the institutional norm)
• Patients < 10 years, Modified Lansky score ≥ 60; patients > 10 years, Karnofsky score ≥ 60
• Patient life expectancy must be at least 8 weeks
• Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian

You may not qualify if…

• Acute infection, granulocytopenia or medical condition precluding surgery
• Pregnant or lactating females
• Prior history of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection
• 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 injection
• Known HIV seropositivity
• Concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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