Is NCT06624371 recruiting in Atlanta, GA?

Yes, NCT06624371 is currently recruiting participants at its Atlanta, GA location. This high-grade glioma clinical trial is actively enrolling qualified participants.

How do I join the high-grade glioma clinical trial in Atlanta?

To join this clinical trial in Atlanta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Atlanta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

High-grade Glioma Clinical Trial in Atlanta, GA

About This High-grade Glioma Study in Atlanta

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.

Sponsor: Emory University

Who Can Participate

Inclusion Criteria

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 tumors are eligible. Diffuse intrinsic pontine glioma (DIPG) defined by MRI does not require histological confirmation.

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 allowed for Stratum 2 only. --Measurable disease is not necessary for enrollment study.

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 study. There is no upper limit to the number of prior therapies that is allowed.

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.

Exclusion Criteria

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 reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment. This should be documented in the electronic medical records as part of the consent discussion. Stratum 2

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 half-lives must have elapsed before enrollment.

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) ≥ 2 weeks.

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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT06624371) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

High-grade Glioma Treatment Options in Atlanta, GA

If you're searching for high-grade glioma treatment options in Atlanta, GA, this clinical trial (NCT06624371) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this clinical trial. You'll receive care from experienced high-grade glioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all high-grade glioma clinical trials near you to find additional studies recruiting in your area.

High-grade Glioma Clinical Trial in Atlanta, GA

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