G207 with 5 Gy Radiation for pediatric high-grade glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial evaluating intratumoral G207 followed by 5 Gy radiation within 24 hours in children with recurrent or progressive high-grade glioma. The primary goal is to see if this combination improves postprogression overall survival compared with historical controls, focusing on patients after one prior progression. Secondary goals include safety/toxicity, virologic shedding, immune responses, radiographic changes, and measures like response rate and progression-free survival. Exploratory aims examine quality of life changes, tissue immune markers, and outcomes by subsequent therapies. The study uses imaging and biomarkers to characterize response and safety, with MD Anderson Cancer Center leading recruitment at UT MD Anderson in Houston, TX.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Exclusion Criteria:

Pregnancy

Pregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Pregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects.

Lactation Status

Lactating females are not eligible unless they have agreed not to breastfeed their infants

Because there is an unknown potential risk for adverse events in nursing infants secondary to treatment of the mother with G207, breastfeeding should be discontinued if the mother is treated with G207.

Disease-Related Exclusion Criteria

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.

Patients with primary tumor involving the cerebellum, brainstem or spinal cord, or that would require surgical access through a ventricle to deliver the prescribed protocol treatment.

Metastatic disease or diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain.

Tumor with evidence of clinically significant uncal herniation or midline shift, or evidence of ventricular obstruction from tumor or tonsillar herniation.

Concurrent Illness

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.

Known HIV seropositivity.

Diagnosis of encephalitis or CNS infection \< 12 weeks prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis.

Concurrent Medications

Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.

Patients who are receiving ≥ 2 mg of dexamethasone (or ≥ 10 mg of prednisone) daily

* Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation
* For this study, 'systemic corticosteroids' include oral, intravenous, or intramuscular formulations. A single, non-consecutive dose does not constitute exclusion. Physiologic corticosteroid replacement therapy (e.g., hydrocortisone for adrenal insufficiency), intermittent use of bronchodilators and topical steroids, is not considered immunosuppressive and does not constitute exclusion.

Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).

Inability to Participate

Patients who in the opinion of the investigator are unwilling or unable to return for required followup visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to the drug administration plan, other study procedures, and study restrictions.

Where it's running

• UT MD Anderson
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Gregory Friedman, MD — UT MD Anderson
• Study coordinator: Gregory Friedman, MD
• Email: gkfriedman@mdanderson.org
• Phone: 713-557-4400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Preoperative Proton Therapy for High-Grade Brain Tumors

  This trial tests whether giving proton therapy before surgery is tolerable for people with high-grade brain gliomas.

  Recruiting Phase 1 National Medical Research Radiological Centre of the Ministry of Health of Russia · Obninsk, Kaluga Oblast · NCT07710040

• Neuro-navigation-guided focused ultrasound with nivolumab for relapsed or progressive high-grade brain tumors in children

  This study tests whether using focused ultrasound to open the blood-brain barrier and give nivolumab is safe and feasible for kids with relapsed or progressive DMG/DIPG or other high-grade brain tumors.

  Recruiting Phase 1 Children's National Research Institute · Washington D.C., District of Columbia · NCT07664176

• Dual-target CAR-NK therapy for adults with recurrent or progressive glioblastoma and other high-grade gliomas

  This study will try giving dual-target CAR-NK cells into the surgical cavity to see if they can help adults with recurrent or progressive glioblastoma or other high-grade gliomas.

  Recruiting Phase 1 Beijing Biotech · Shenzhen, Guangdong · NCT07551336

• Pre-radiation chemotherapy for high-grade glioma

  Researchers are testing whether giving temozolomide before radiation can help patients with newly diagnosed high-grade gliomas see better outcomes and clearer MRI results after treatment.

  Recruiting Phase 2 Cooper Norcross Health · Camden, New Jersey · NCT07439172

• AAV dual-payload gene therapy injected directly into high-grade glioma to kill tumor cells and stimulate immune attack.

  This will try TGX-007, a virus-delivered gene therapy given into the tumor together with oral valaciclovir, in adults 18–70 with newly diagnosed or recurrent glioblastoma to see if it safely kills tumor cells and boosts immune response.

  Recruiting at 2 sites Phase 1/2 Trogenix ltd · Columbus, Ohio and 1 other locations · NCT07346144

• Fluorescent-labeled nivolumab (Nivo800) imaging for high-grade glioma surgery

  This trial tests whether a near-infrared fluorescent version of the immunotherapy drug nivolumab can be given before planned surgery to visualize drug distribution in adults with suspected high-grade glioma.

  Recruiting Early Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07210632

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.