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DISEASE CHARACTERISTICS:
- Histologically confirmed intracranial low-grade glioma* at initial diagnosis,
including any of the following histological subtypes:
- Astrocytoma
- No pilocytic astrocytomas
- Oligodendroglioma
- Mixed oligoastrocytoma NOTE: *Histologically confirmed progression to high-grade
gliomas are allowed provided patient has undergone prior radiotherapy
- Evaluable disease
- Unequivocal evidence of tumor recurrence or progression by histology and MRI, as
determined by the following:
- Histological review of pathology by an attending neuro-pathologist at the
University of California San Francisco (UCSF)
- Radiographic review of MRI* (performed within the past 14 days) by an attending
neuro-oncologist or neuro-radiologist at UCSF NOTE: *MRI must be performed after
≥ 5 days on a stable dose of steroids or a new baseline MRI is required
- Paraffin-embedded tissue samples acquired from surgery at time of recurrence must be
available
- No leptomeningeal or uncontrolled brain metastases, including those who require
glucocorticoids for their metastases
- Must be registered in University of California San Francisco Neuro-Oncology database
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy > 8 weeks
- ANC ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin > 9 g/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- INR < 1.3 (or < 3 on anticoagulants)
- ALT and AST ≤ 2.5 times ULN
- Serum creatinine ≤ 1.5 times ULN
- Fasting serum cholesterol* ≤ 300 mg/dL OR ≤ 7.75 mmol/L
- Fasting triglycerides* ≤ 2.5 times ULN NOTE: *If one or both of these thresholds is
exceeded, the patient can only be included after initiation of appropriate lipid
lowering medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant medical illnesses that, in the opinion of the investigator, cannot be
adequately controlled with appropriate therapy, or would compromise the patient's
ability to tolerate study therapy
- No other cancer except nonmelanoma skin cancer or carcinoma in-situ of the cervix,
unless in complete remission and off all therapy for that disease within the past 3
years
- No active, bleeding diathesis
- No severe and/or uncontrolled medical conditions or other conditions that would
preclude participation in the study, including any of the following:
- NYHA class III-IV symptomatic congestive heart failure
- Unstable angina pectoris
- Myocardial infarction within the past 6 months
- Serious uncontrolled cardiac arrhythmia
- Other clinically significant cardiac disease
- Severely impaired lung function (i.e., oxygen [O_2] saturation 88% or less at
rest on room air by pulse oximetry must undergo further pulmonary function tests
to confirm normal pulmonary function and eligibility)
- Uncontrolled diabetes, defined by fasting serum glucose > 1.5 times ULN
- Active (acute or chronic) or uncontrolled severe infections
- Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent
hepatitis)
- No impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of everolimus, including any of the following:
- Ulcerative disease
- Uncontrolled nausea
- Vomiting
- Diarrhea
- Malabsorption syndrome
- Small bowel resection
- No known HIV positivity
- No known hypersensitivity to everolimus or other rapamycins (i.e., sirolimus,
temsirolimus) or to its excipients
- No history of noncompliance to medical regimens
- Must be willing and able to comply with the protocol
PRIOR CONCURRENT THERAPY:
- Recovered from all prior therapy
- Treatment for relapses prior to this recurrence allowed
- No prior therapy for this recurrence (e.g., radiotherapy)
- Supportive care (e.g., steroids or antiepileptics) does not constitute treatment
of recurrence)
- No prior mTOR inhibitor (i.e., sirolimus, temsirolimus, or everolimus)
- More than 5 days since prior enzyme-inducing antiepileptic agent
- More than 1 week since prior and no concurrent immunization with attenuated live
vaccines
- Less than 4 months since prior surgical procedure for this recurrence
- At least 2 weeks since prior non-cytotoxic or biologic agents (e.g., interferon,
tamoxifen, thalidomide, or cis-retinoic acid)
- At least 4 weeks since prior radiotherapy
- At least 4 weeks since prior cytotoxic therapy (≥ 6 weeks since nitrosourea, 3 weeks
since procarbazine, and 2 weeks since vincristine)
- At least 4 weeks since prior and no concurrent investigational agent
- No other concurrent anticancer agents
- Concurrent enzyme-inducing antiepileptic agents allowed provided treatment is limited
to no more than 10 days during study
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