Atovaquone Combined With Radiation in Children With Malignant Brain Tumors

Exclusion Criteria

• •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 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:
• •1. 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.
• •2. Biologic or investigational agent (anti-neoplastic): Patient must have received their last dose of the investigational or biologic agent ≥ 7 days before study enrollment.
• •3. 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.
• •4. Immunotherapy: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses. etc.) at least 42 days before enrollment.
• •5. 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.
• •6. 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.
• •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.