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New treatment option for Neoplasms, Brain
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 medicine, being studied as a potential treatment for neoplasms, brain.
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
- 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.
- 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 3 to 21
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...
- 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...
- Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering...
- Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)
You likely can't join if
- 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
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...
- 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...
- 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...
- 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) \ 60 mL/min/1.73 m2 for patients with...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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, 3 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; St Louis, Missouri, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.