SUSPENDED

HSV G207 With a Single Radiation Dose in Children With Recurrent High-Grade Glioma

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Conditions

NeoplasmsHigh Grade GliomaGlioblastoma MultiformeMalignant Glioma of BrainAnaplastic Astrocytoma of BrainHigh-grade GliomaAnaplastic GliomaGiant Cell GlioblastomaBrain Tumor, Recurrentgliomaoncolytic virotherapyimmunotherapyimmunovirotherapyneoplasmprogressivevirusHSVherpes virusherpes simplex virusoncolytic 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 assess the efficacy and confirm the safety of intratumoral inoculation of G207 (an experimental virus therapy) combined with a single 5 Gy dose of radiation in recurrent/progressive pediatric high-grade gliomas

Official Title

Phase II Clinical Trial of HSV G207 With a Single 5 Gy Radiation Dose in Children With Recurrent High-Grade Glioma

Quick Facts

Study Start:2025-09-01
Study Completion:2030-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04482933

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 CriteriaExclusion Criteria
  1. * Patients must have a histologically confirmed diagnosis of high-grade glioma regardless of molecular characterization that is recurrent or progressive. All tumors must have histologic verification at either the time of diagnosis or recurrence.
  2. * Patients are only eligible after their first progression following prior surgery and radiotherapy
  3. * Supratentorial lesion must be ≥ 1.0 cm in longest dimension and surgically accessible as determined by contrast-enhanced MRI
  4. * For patients with tumors \> 4.0 cm without an adjacent cavity, the neurosurgeon must be confident that the tumor can be debulked to ≤ 4.0 cm for eligibility.
  5. * Multifocal disease on the ipsilateral side is eligible if at least one catheter can be placed in all multifocal areas
  6. * Tumor size will be determined using the maximal 2-dimensional cross-sectional tumor measurements, transverse x width, using either T1 images or T2/FLAIR images for non-enhancing tumors.
  7. * Patient must be ≥ 3 at initial diagnosis but \< 22 years of age at the time of enrollment on this study.
  8. * Prior therapy: Patients must have received prior surgery and radiotherapy and recovered from the acute treatment related toxicities (defined as ≤ Grade 1 if not defined in eligibility criteria; excludes alopecia) prior to enrollment.
  9. * Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea.
  10. * Biologic or investigational agents (anti-neoplastic): patients must have received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
  11. * Monoclonal antibodies and agents with known prolonged half-lives: Patient must have received their last dose of the agent ≥ 28 days prior to study enrollment.
  12. * Immune Effector Cell (IEC) Therapy (e.g., CAR T cells): For viral therapy or cellular therapy, patients must have received therapy ≥ 3 months prior to study enrollment.
  13. * Radiation: Patients must have received their last fraction of standard radiation ≥ 3 months prior to study entry.
  14. * Stem Cell Transplant: Patient must be:
  15. * ≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease.
  16. * ≥ 3 months since autologous stem cell transplant prior to enrollment.
  17. * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment. A baseline detailed neurological exam should clearly document the neurological status of the patient at the time of enrollment on the study.
  18. * Patients with seizure disorders may be enrolled if seizures are well controlled.
  19. * Karnofsky Performance Scale (KPS for children \> 16 years of age) or Lansky Performance Score (LPS for children ≤ 16 years or age) assessed within 7 days prior to enrollment must be ≥ 60. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  20. * Patients must have adequate organ and marrow function as defined below:
  21. * Absolute neutrophil count \> 1.0 x 109 cells/L
  22. * Platelets \> 100 x 109 cells/L (unsupported, defined as no platelet transfusion within 7 days)
  23. * Hemoglobin ≥ 8 g/dL (may receive transfusions)
  24. * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  25. * PT/INR, PTT ≤ 1.5 x ULN
  26. * ALT(SGPT) and AST (SGOT) \< 3 x institutional upper limit of normal (ULN)
  27. * Albumin ≥ 3 g/dL
  28. * Serum creatinine based on age/gender as noted in Table 2. Patients that do not meet the criteria in Table 2 but have a Cystatin C, 24-hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 mL/min/1.73 m2 are eligible.
  29. * Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment.
  30. * Growth Factors: Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (e.g., filgrastim, sargramostim, or erythropoietin). Two (2) weeks must have elapsed if the patient received a long-acting formulation.
  31. * Pregnancy Prevention: Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
  1. * Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to undergo surgery and/or tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
  2. * Known HIV seropositivity.
  3. * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.
  4. * Patients with a secondary high-grade glioma are ineligible.
  5. * Patient with primary tumor involving the cerebellum, brainstem or spinal cord or that would require surgical access through a ventricle in order to deliver the prescribed protocol treatment.
  6. * Metastatic disease or diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain
  7. * Tumor with evidence of clinically significant uncal herniation or midline shift, or evidence of ventricular obstruction from tumor or tonsillar herniation
  8. * Diagnosis of encephalitis or CNS infection \< 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection, or multiple sclerosis
  9. * Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
  10. * Patients who are receiving ≥ 1.5 mg of dexamethasone (or ≥ 10 mg of prednisone) daily
  11. * Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir)
  12. * Patients may not be on immunosuppressive therapy, including corticosteroids (except for patients receiving \< 1.5 mg of dexamethasone or \< 10 mg of prednisone daily) at time of enrollment. However, patients who require intermittent use of bronchodilators or topical steroids will not be excluded from the study.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Holly Lindsay MD
Aurora, Colorado, 80045
United States
Memorial Sloan Kettering
New York, New York, 14263
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Pediatric Brain Tumor Consortium

  • 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 Date2025-09-01
Study Completion Date2030-02-15

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2030-02-15

Terms related to this study

Keywords Provided by Researchers

  • Brain Tumor, Recurrent
  • glioma
  • oncolytic virotherapy
  • immunotherapy
  • immunovirotherapy
  • neoplasm
  • progressive
  • virus
  • HSV
  • herpes virus
  • herpes simplex virus
  • oncolytic virus

Additional Relevant MeSH Terms

  • Neoplasms
  • High Grade Glioma
  • Glioblastoma Multiforme
  • Malignant Glioma of Brain
  • Anaplastic Astrocytoma of Brain
  • High-grade Glioma
  • Anaplastic Glioma
  • Giant Cell Glioblastoma