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Assessment of Systemically Administered Torisel Delivery to Brain Tumors by Intratumoral Microdialysis

Phase 1
18 Years
Not Enrolling
Brain Neoplasms

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Trial Information

Assessment of Systemically Administered Torisel Delivery to Brain Tumors by Intratumoral Microdialysis

Inclusion Criteria:

1. Patients must be at least 18 years of age.

2. Patients must have histologically confirmed supratentorial grade III or IV
astrocytoma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma
multiforme) and require a stereotactic biopsy for confirmation of tumor progression
or differentiation of tumor progression from treatment induced effects following
radiation therapy ± chemotherapy. Patients with previous low-grade glioma who
progressed after radiotherapy ± chemotherapy and are in need of a stereotactic biopsy
to confirm the presence of a high-grade glioma, and this is accomplished at the time
of biopsy, are eligible.

3. Patients must have a Karnofsky performance status ≥ 50% (i.e. the patient must be
able to care for himself/herself with occasional help from others).

4. Patients must have had prior radiation therapy.

5. The patient is a candidate for temsirolimus as the next therapy for their tumor and
the treating physician and the patient must be planning to continue temsirolimus
chemotherapy after receiving the one dose required for this study.

6. Patients must have recovered from the toxicity of prior therapy. An interval of at
least 3 months must have elapsed the since the completion of the most recent course
of radiation therapy while at least 3 weeks must have elapsed since the completion of
a non-nitrosourea containing chemotherapy regimen and at least six weeks since the
completion of a nitrosourea containing chemotherapy regimen.

7. Patients must have adequate bone marrow function (defined as an absolute neutrophil
count of >1500 cells/mm3 and platelet count >100,000 cells/mm3), liver function with
Total bilirubin <2.0 mg/dl and SGOT <4 times upper limit of normal, and adequate
renal function with serum creatinine ≤ 2 mg/dl, creatinine clearance (24 hour
collection) >50 cc/min. (Required labs must be within -7 days of catheter placement)

8. Patients must be able to provide written informed consent.

9. Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception. Women of child bearing
potential must have negative pregnancy test. The anti-proliferative activity of
temsirolimus may be harmful to the developing fetus or nursing infant.

10. Patients must not be allergic to temsirolimus or rapamycin.

Exclusion Criteria:

1. Patients with serious concurrent infection or medical illness, which would jeopardize
the ability of the patient to receive the chemotherapy outlined in this protocol with
reasonable safety.

2. Patients who are pregnant or breast-feeding.

3. Patients without MRI or CT evidence of measurable, contrast-enhancing residual
disease are not eligible.

4. Patients receiving concurrent chemotherapeutic or investigational agents.

Type of Study:


Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Microdialysate torisel concentration

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Jeffrey Olson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

May 2010

Related Keywords:

  • Brain Neoplasms
  • Brain Cancer
  • Brain Neoplasms, Malignant
  • Brain Neoplasms
  • Neoplasms



Emory University Winship Cancer InstituteAtlanta, Georgia  30322