HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Launched by M.D. ANDERSON CANCER CENTER · Apr 9, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called G207, which is an experimental virus therapy designed to target certain types of brain tumors in children and young adults. Specifically, it focuses on those with recurrent or hard-to-treat cerebellar brain tumors, which are located in the back part of the brain. The trial aims to understand how safe it is to use G207, especially when combined with a low dose of radiation that could help the virus work better against the tumor.

To participate in this trial, patients need to be between 3 to 21 years old and have a confirmed diagnosis of a malignant cerebellar brain tumor that has not responded to standard treatments like surgery or chemotherapy. They must also meet certain health criteria, such as having normal blood counts and having recovered from any previous cancer treatments. If eligible, participants will receive the G207 treatment and will be monitored closely for any side effects or changes in their condition. This trial is an important step in exploring new options for children who have limited treatment choices for their brain tumors.

Gender

ALL

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 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
• Exclusion Criteria:
• • 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