Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas

Exclusion Criteria

• •Presence of NF1 by clinical examination or by genetic testing
• •Patients who have had a major surgery or significant traumatic injury within 2 weeks of start of study drug, patients who have not recovered from teh side effects of any major surgery, or patients that may require major surgery during the course of the study
• •Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled are allowed
• •Evidence of plexiform neurofibroma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy
• •Uncontrolled brain or leptomeningeal metastases from plexiform neurofibromas, malignant peripheral nerve sheath tumors, or other cancers (other than astrocytoma variants; fibrillary, protoplasmic, mixed: Pilocytic astrocytoma; including pilomyxoid variants: Pleomorphic xanthoastrocytoma: infantile desmoplastic astrocytoma: ganglioglioma: oligodendroglial tumors: mixed glioma), including patients who continue to require glucocorticoids for control of symptoms related to brain or leptomeningeal metastases.
• •Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
• •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study (see protocol for examples)
• •Known history of HIV seropositivity
• •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
• •Active, bleeding diathesis or oral anti-vitamin K medication (except low dose coumarin)
• •Female patients who are pregnant or breast feeding
• •Prior treatment with an mTOR inhibitor
• •Known hypersensitivity to RAD001 or other rapamycins or to is excipients
• •Dental braces or prosthesis that interferes with tumor imaging
• •Patients with a positive history of Hepatitis B or Hepatitis C
• •Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.