RECRUITING

HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

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 Brain Tumor, Recurrent Glioma Gliosarcoma Medulloblastoma Anaplastic Astrocytoma Oligodendroglioma Rhabdoid Tumor Ependymoma Germ Cell Tumor Choroid Plexus Carcinoma Cerebral Primitive Neuroectodermal Tumor Giant Cell Glioblastoma Atypical teratoid/rhabdoid tumor Secondary Malignant Cerebellar Tumor Embryonal Tumor Oncolytic Virus Therapy Virotherapy, Oncolytic Immunotherapy Central Nervous System Agents Antineoplastic Agents Pediatric Pediatrics Oncolytic Herpes Virus G207 Oncolytic Herpes Virus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Quick Facts

Study Start:2019-09-12

Study Completion:2027-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03911388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 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: The 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 creatinine clearance \>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 \< 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance 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	* Any treatment outside the allowable guidelines outlined in section 5.1. * Diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain * Acute infection, granulocytopenia or medical condition precluding surgery * Pregnant or lactating females * Diagnosis of encephalitis or CNS infection \< 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis * Tumor involvement which would require ventricular 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 \>2 mg of dexamethasone daily * Known HIV seropositivity * Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone). * Other current malignancy * Concurrent anticancer or investigational drug

Inclusion Criteria

Exclusion 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 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: The 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 creatinine clearance \>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 \< 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance 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

* Any treatment outside the allowable guidelines outlined in section 5.1.
* Diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain
* Acute infection, granulocytopenia or medical condition precluding surgery
* Pregnant or lactating females
* Diagnosis of encephalitis or CNS infection \< 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis
* Tumor involvement which would require ventricular 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 \>2 mg of dexamethasone daily
* Known HIV seropositivity
* Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).
* Other current malignancy
* Concurrent anticancer or investigational drug

Contacts and Locations

Study Contact

Kara Kachurak, CRNP

CONTACT

832-750-5661l

kgkachurak@mdanderson.org

Gregory K Friedman, MD

CONTACT

gkfriedman@mdanderson.org

Principal Investigator

Gregory Friedman, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

Children's of Alabama

Birmingham, Alabama, 35233

United States

St. Louis Children's Hospital

Saint Louis, Missouri, 63110

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Gregory Friedman, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-12

Study Completion Date2027-09-01

Study Record Updates

Study Start Date2019-09-12

Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

Brain Tumor, Recurrent
Glioma
Glioblastoma Multiforme
Gliosarcoma
Medulloblastoma
Anaplastic Astrocytoma
Oligodendroglioma
Rhabdoid Tumor
Ependymoma
Germ Cell Tumor
Choroid Plexus Carcinoma
Cerebral Primitive Neuroectodermal Tumor
Giant Cell Glioblastoma
Atypical teratoid/rhabdoid tumor
Secondary Malignant Cerebellar Tumor
Embryonal Tumor
Neoplasms
Oncolytic Virus Therapy
Virotherapy, Oncolytic
Immunotherapy
Central Nervous System Agents
Antineoplastic Agents
Pediatric
Pediatrics
Oncolytic
Virus
HSV
Herpes Virus
G207
Oncolytic Herpes Virus

Additional Relevant MeSH Terms

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