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Recruiting Phase 1 NCT03911388

HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Trial Parameters

Condition Neoplasms, Brain
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 24
Sex ALL
Min Age 3 Years
Max Age 21 Years
Start Date 2019-09-12
Completion 2026-09-01
All Conditions
Neoplasms, Brain Glioblastoma Multiforme Glioblastoma of Cerebellum Neoplasms Astrocytoma Astrocytoma, Cerebellar Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Cerebellar PNET, Childhood Cerebellar Neoplasms Cerebellar Neoplasms, Primary Cerebellar Neoplasm, Malignant Cerebellar Neoplasm Malignant Primary Neoplasm Metastases Neoplasm Malignant Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms, Primary Central Nervous System Neoplasms, Malignant Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Medulloblastoma Recurrent HSV Virus Pediatric Brain Tumor Nervous System Cancer Primitive Neuroectodermal Tumor (PNET) of Cerebellum
Interventions
G207

Brief Summary

This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested. Funding Source- FDA OOPD

Eligibility Criteria

Inclusion Criteria: * Age ≥ 36 months and \< 22 years * Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, 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 cerebellar tumor without curative treatment options is eligible. * Lesion must be ≥ 1.0 cm ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking * 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 p

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