Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patients must have histologic verification of one of the eligible diagnoses listed here: Astrocytoma variants; fibrillary, protoplasmic, mixed: Pilocytic astrocytoma; including pilomyxoid variants: Pleomorphic xanthoastrocytoma: infantile desmoplastic astrocytoma: ganglioglioma: oligodendroglial tumors: mixed glioma.
Patients must have received at least one cancer-directed therapy and patients with allergies to carboplatin must have demonstrated progressive disease after cessation of therapy.
Must have at least one measurable site of disease that has not been previously irradiated. If the patient has previous irradiation to the marker lesion(s), there must be evidence of progression since radiation treatment.
Patients must be between 3 years of age and 21 years of age
Karnofsky Performance Status of 50% or greater for patients less than 10 years of age or Lansky Score of 50% or greater for patients 10 and up.
Participants must have recovered from the acute toxic effects of all prior chemotherapy or radiotherapy prior to entering the study. Refer to protocol for specific time restrictions with prior therapy completion.
Adequate bone marrow function as defined in protocol
Adequate renal function as defined in protocol
Adequate liver function as defined in protocol
Patients must have a fasting LDL cholesterol within the normal range per institutional guidelines
Patients taking cholesterol lowering agent must be on a single medication and on a stable dose for at least 4 weeks
Fasting serum cholesterol as outlined in protocol
Patients must not be taking enzyme-inducing anticonvulsants
Patients may not be currently receiving strong inhibitors of CYP3A4

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.