CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
About this trial
This is an interventional treatment trial for Adult Giant Cell Glioblastoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed grade 4 astrocytoma at primary diagnosis or recurrence Gliosarcoma allowed Evidence of tumor progression by MRI or CT scan after radiotherapy or first-line chemotherapy Measurable or evaluable disease by MRI or CT scan Performance status - ECOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal Creatinine no greater than 2.0 mg/dL No myocardial infarction within the past 6 months No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias Cholesterol no greater than 350 mg/dL Triglycerides no greater than 400 mg/dL Willing to provide correlative laboratory samples No uncontrolled infection No known hypersensitivity to any components of CCI-779, diphenhydramine hydrochloride, or other similar antihistamines No other medical reason that would preclude diphenhydramine premedication No other active malignancy No other severe disease that would preclude study participation Not immunocompromised unless due to corticosteroids HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception See Disease Characteristics Prior adjuvant chemotherapy allowed More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No more than 1 prior chemotherapy regimen for recurrent/progressive disease No prior polifeprosan 20 with carmustine implant (Gliadel) Must be on fixed dose of corticosteroids (or no corticosteroids) at least 1 week prior to baseline scan See Disease Characteristics At least 12 weeks since prior radiotherapy No prior stereotactic radiosurgery or interstitial brachytherapy unless there is a separate lesion on MRI that is outside of the previously treated field No prior resection since last chemotherapy or radiotherapy unless there is unequivocal tumor growth on neuro-imaging study since surgery or there is a separate lesion not present in the surgical bed More than 4 weeks since prior investigational agents
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.