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New treatment option for High-grade Glioma
Official title Atovaquone Combined With Radiation in Children With Malignant Brain Tumors
ClinicalTrials.gov ID: NCT06624371
What this study is testing
What is Atovaquone?
Atovaquone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for high-grade glioma.
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 goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma/diffuse midline glioma/diffuse intrinsic pontine glioma (pHGG/DMG/DIPG). The secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG/DMG/DIPG and medulloblastoma (MB) or pHGG/DMG/DIPG after completion of RT and before progression.
- 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 2 to 25
You may be able to join if
- -Stratum 1
- Newly diagnosed pHGG/DMG/DIPG Patients must have histologically confirmed pediatric high-grade glioma (pHGG, WHO Grade 3 or 4) or diffuse midline...
- Weight \> 10kg
- Karnofsky and Lansky performance score \> 50%
- Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.
You likely can't join if
- Stratum 1
- Chronic systemic concurrent illness
- Concurrent or history of anti-cancer therapy other than RT
- Patients with metastatic tumor are excluded for Stratum 1 only.
- Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.
- Patients must fully recover from all acute effects of prior surgical intervention.
See the full eligibility criteria
Who can join
- -Stratum 1
- Newly diagnosed pHGG/DMG/DIPG Patients must have histologically confirmed pediatric high-grade glioma (pHGG, WHO Grade 3 or 4) or diffuse midline glioma with altered H3K27 (DMG, WHO Grade 4). Primary pHGG or DMG spinal...
- Weight \> 10kg
- Karnofsky and Lansky performance score \> 50%
- Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.
- Adequate liver function defined as:
- Total bilirubin ≤ 2x upper limit of normal (ULN) and
- AST (SGOT) and ALT (SGPT) ≤ 225 U/L (5x the ULN). The ULN for AST and ALT will be 45 U/L.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count \> 1,000/mcL
- platelets \> 100,000/mcL
- hemoglobin \> 8g/dL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) \< 5 x (\<10 x if taking steroids) the institutional upper limit of normal
- creatinine within normal institutional limits for age 2 OR
- creatinine clearance \> 60mL/min/1.73 m for patients with creatinine levels above institutional normal Stratum 2
- Relapsed, progressive pHGG/DMG/DIPG and medulloblastoma (MB) or pHGG/DMG/DIPG after completion of standard radiation therapy without prior atovaquone exposure and before progression. Patients with metastatic disease are...
- Patients must have previously undergone standard-of-care treatment including surgery, radiation, and/or first-line adjuvant chemotherapy before the experimental treatment (atovaquone).
- Patients must have recovered from the acute treatment-related toxicities (defined as \< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this...
- Age \> 2 to 25 years
- Weight \> 10kg
- Karnofsky and Lansky performance score \> 50%
- Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.
- Patients must have normal organ and marrow function as defined above for Stratum 1
- Adequate liver function is defined as:
- Total bilirubin ≤ 2x upper limit of normal (ULN) and
- AST (SGOT) and ALT (SGPT) ≤ 225 U/L (5x the ULN). The ULN for AST and ALT will be 45 U/L.
What rules you out
- Stratum 1
- Chronic systemic concurrent illness
- Concurrent or history of anti-cancer therapy other than RT
- Patients with metastatic tumor are excluded for Stratum 1 only.
- Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.
- Patients must fully recover from all acute effects of prior surgical intervention.
- History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.
- Symptomatic intratumoral hemorrhage, or asymptomatic intratumoral hemorrhage larger than punctate foci, at any time prior to enrollment.
- Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of...
- Concurrent illness
- Patients must have recovered from all prior therapy as follows:
- Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks before study enrollment or at least six (6) weeks if prior nitrosourea.
- Biologic or investigational agent (anti-neoplastic): Patient must have received their last dose of the investigational or biologic agent ≥ 7 days before study enrollment.
- Antibodies: ≥ 21 days must have elapsed from an infusion of the last dose of antibody and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1. Agents with prolonged half-lives: At least three...
- Immunotherapy: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses. etc.) at least 42 days before enrollment.
- Radiation: Patients must have had their last fraction of Craniospinal irradiation ≥ 3 months before enrollment. Other substantial bone marrow irradiation ≥ 6 weeks before enrollment Local or palliative XRT (small port)...
- Stem Cell Transplant: Patient must be ≥ 12 weeks since autologous bone marrow/stem cell transplant before enrollment. Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic...
- Patients must fully recover from all acute effects of prior surgical intervention.
- History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.
- Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, 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, 2 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, 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.