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Anti-parasitic agent

Atovaquone + Radiation for Pediatric Brain Cancer (AflacBT2303 Trial)

Phase 1

Recruiting

Led By Tobey MacDonald, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stratum 1: Karnofsky and Lansky performance score > 50%

Stratum 2: Karnofsky and Lansky performance score > 50%

Must not have

Stratum 1: Concurrent or history of anti-cancer therapy other than RT

Stratum 1: Symptomatic or large asymptomatic intratumoral hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if atovaquone, when used with standard radiation therapy, is safe and tolerable for treating pediatric patients with certain types of brain tumors. They also want to see if

Who is the study for?

This trial is for children with newly diagnosed high-grade brain tumors, including diffuse intrinsic pontine glioma and medulloblastoma. Participants must meet specific health criteria to be eligible. The full list of inclusion and exclusion criteria was not provided.

What is being tested?

The study tests the safety of atovaquone when used with standard radiation therapy in treating pediatric brain tumors. It also looks at how well patients tolerate long-term atovaquone treatment after radiation therapy.

What are the potential side effects?

While the exact side effects are not detailed here, potential side effects may include those commonly associated with radiation therapy such as fatigue, hair loss, skin irritation, and nausea; plus any known reactions to atovaquone like stomach pain or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities but may need help.

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I can do most activities but may need help.

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My liver and other organs are functioning normally.

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My brain tumor has returned or worsened after standard treatment.

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I have completed the standard treatment for my condition.

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My seizures are under control and not getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had cancer treatment other than radiation.

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I have bleeding in my tumor, which causes symptoms or is large.

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My cancer has spread to other parts of my body.

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I have seizures that are not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drug Limiting toxicities (DLT) in Stratum 1

Drug Limiting toxicities (DLT) in Stratum 2

Secondary study objectives

Objective Tumor Response Rate (ORR) for Stratum 2

Overall survival (OS) in newly diagnosed pHGG/DMG/DIPG patients (Stratum 1)

Overall survival in Stratum 2 subjects

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stratum 2Experimental Treatment2 Interventions

Stratum 2 will be bifurcated into: * Stratum 2a (patients with relapse or progression) * Stratum 2b (patients without progression after radiation) The same dosing regimen for atovaquone will be used for up to 6 months in the absence of toxicity, intolerance, or tumor progression. Patients will begin therapy between 2-4 weeks after documented relapse or progression of tumor or between 2-4 weeks after completion of standard RT for pHGG/DMG/DIPG patients who have completed standard Radiotherapy without previous atovaquone treatment.

Group II: Stratum 1:Experimental Treatment2 Interventions

Newly diagnosed pHGG/DMG/DIPG patients. New Diagnosis followed by 2 weeks (+/- 7 days) atovaquone followed by approx. 6 weeks Atovaquone + Radiotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atovaquone

2012

Completed Phase 1

~80

Radiation Therapy

2017

Completed Phase 3

~7250