Metastatic Cancer Clinical Trial
Official title:
A Pilot Feasibility, Dose-Escalation Study Using Intracerebral Microdialysis to Assess the Neuropharmacodynamics of Temsirolimus in Patients With Primary or Metastatic Brain Tumors
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Studying samples of blood and tumor tissue from patients with cancer
in the laboratory may help doctors learn more about how this treatment is used by the body.
PURPOSE: The purpose of this study is to evaluate the feasibility of using a microdialysis
catheter to see what effect temsirolimus has on various biological substances associated with
brain tumors over time.
OBJECTIVES:
Primary
- Determine the feasibility of using a microdialysis catheter with a high cut-off membrane
to perform neuropharmacodynamics (nPD) assessment of targeted therapy with a mammalian
target of rapamycin (mTOR) inhibitor, where nPD is defined as changes in intracerebral
levels of vascular endothelial growth factor (VEGF), interleukin-1ß (IL-1ß), and other
cytokines.
Secondary
- Assess the relationship between temsirolimus dose and changes in intracerebral levels of
VEGF, IL-1ß, and other cytokines.
- Compare changes in intracerebral cytokine levels to changes in systemic cytokine levels.
- Assess the relationship between the degree of microvascular proliferation and the tensin
homologue deleted on chromosome 10 (PTEN) status in tumor tissue.
- Assess the relationship between changes in intracerebral cytokine levels after treatment
with temsirolimus.
OUTLINE: Two cohorts of 6 patients will be enrolled in this study. All patients undergo
debulking craniotomy or stereotactic biopsy and a placement of a intracerebral CMA 71
microdialysis (ICMD) catheter. Patients then are assigned to 1 of 2 treatment cohorts.
- Cohort 1: Patients do not receive temsirolimus. Dialysate samples will be collected at
regular intervals during the 96 hours following placement of the catheter as well as
serial blood samples to measure levels of cytokines, chemokines and growth factors that
occur after neurosurgery.
- Cohort 2: Beginning 48 hours after surgery, patients receive a single 200 mg dose of
temsirolimus IV. Dialysate samples will be collected at regular intervals during the 96
hours following placement of the catheter as well as serial blood samples to measure
levels of cytokines, chemokines and growth factors that occur after neurosurgery. Plasma
levels of temsirolimus and sirolimus will also be measured from the serial blood
samples.
After completion of study therapy and removal of ICMD catheter, patients are followed for 30
days.
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