Clinical Trial Finder

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

OBJECTIVES:

• I. Determine the efficacy of CCI-779, in terms of the percentage of patients who are progression-free at 6 months, time to progression, and time to death, in patients with recurrent glioblastoma multiforme.

• II. Determine the toxic effects of this drug in these patients.

• III. Correlate molecular alterations in the tumors of these patients with response to treatment with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to concurrent P450 anticonvulsant use (yes vs.#46;no). 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. Patients are followed every 6 months for 5 years and then annually for up to 10 years. PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 39 months.

Arms

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.

Interventions

Drug: - temsirolimus

Given IV

Other: - laboratory biomarker analysis

Correlative studies

Other: - pharmacological study

Correlative studies