Neoplasms, Brain study: G207
Official title HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
ClinicalTrials.gov ID: NCT03911388
What this study is testing
What is G207?
G207 is an investigational biological therapy being studied for recurrent or refractory cerebellar brain tumors. is designed to selectively replicate in and kill cancer cells while sparing normal cells.
Also referred to as HSV G207.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine how safe it is to inject the experimental virus G207 into these tumors, and whether adding a single low dose of radiation makes it safer or more effective.
- Who it's for
- Children who have cerebellar brain tumors that have come back or do not respond to standard treatments.
- What's involved
- Participants will receive injections of the G207 virus directly into the tumor, and some may also receive a small dose of radiation. They will have regular medical visits and tests to monitor safety.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 36 to 22
You may be able to join if
- Age ≥ 36 months and \< 22 years
- Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic...
- A review of the MRI scan will be necessary to determine if the tumor location and size are such that the patient may be included in the study.
- Patients must have fully recovered from acute treatment-related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to the date...
- Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea) to G207...
You likely can't join if
- Acute infection, granulocytopenia or medical condition precluding surgery
- Pregnant or lactating females
- Diagnosis of encephalitis or central nervous system (CNS) infection ≤ 3 months prior
- 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
- Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation or requires ongoing systemic...
See the full eligibility 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...
- A review of the MRI scan will be necessary to determine if the tumor location and size are such that the patient may be included in the study.
- Patients must have fully recovered from acute treatment-related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to the date of G207 administration.
- Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea) to G207 administration.
- Monoclonal antibodies: patient must have received the last dose ≥ 21 days prior to G207 administration
- Investigational/Biologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to G207 administration (this period must be extended beyond...
- Viral therapy: Patients must have received viral therapy ≥ 3 months prior to G207 administration and must have recovered from all acute toxicities potentially related to the agent
- Radiation: Patients must have received their last fraction of craniospinal radiation (\>24 Gy) or total body irradiation ≥ 3 months prior to G207 administration.
- Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to G207 administration.
- Absolute neutrophil count \> 1000/mm3
- Platelets ≥ 100,000/mm\^3
- 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 m\^2 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
- Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from patient or legal guardian
- Acute infection, granulocytopenia or medical condition precluding surgery
- Pregnant or lactating females
- Diagnosis of encephalitis or central nervous system (CNS) infection ≤ 3 months prior
- 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
- Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation or requires ongoing systemic corticosteroid therapy at a dose \> 2 mg/day of dexamethasone (or...
- Known human immunodeficiency virus (HIV) seropositivity
- Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen for this trial
- Concurrent anticancer or investigational drug
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- St Louis, Missouri, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 36 months to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; St Louis, Missouri, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.