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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949026
Recruitment Status : Withdrawn (No accrual)
First Posted : July 30, 2009
Last Update Posted : November 21, 2013
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Jeffrey James Olson, Emory University

Brief Summary:
The primary purpose of this study is to determine if it is effective to take samples of fluid from the patient's brain tumor with a microdialysis catheter for Torisel measurement. The investigators are also doing it to learn if it is safe to do so. The investigators will use these samples to measure how much Torisel reaches the patient's brain tumor. The use of the microdialysis catheter to collect brain fluid is an FDA approved method. This catheter is already being used in patients who have sustained severe brain trauma from head injuries. The catheter itself is smaller in size than the standard needle that will be used to take the patient's biopsy. To obtain additional information Torisel will also be measured at the same time in the patient's cerebral spinal fluid by taking it from a catheter placed in the patient's cerebral spinal fluid producing spaces in their brain and in their blood from a catheter in one of their vessels.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Drug: Temsirolimus (Torisel) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Systemically Administered Torisel Delivery to Brain Tumors by Intratumoral Microdialysis
Study Start Date : July 2009
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: A Drug: Temsirolimus (Torisel)
Dose de-escalation dependent on microdialysis results
Other Name: Torisel

Primary Outcome Measures :
  1. Microdialysate torisel concentration [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Toxicity assessment [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949026

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United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Wyeth is now a wholly owned subsidiary of Pfizer
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Principal Investigator: Jeffrey Olson, MD Emory University Winship Cancer Institute
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Responsible Party: Jeffrey James Olson, Principal Investigator, Emory University Identifier: NCT00949026    
Other Study ID Numbers: IRB00008256
WCI1388-07 ( Other Identifier: Other )
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013
Keywords provided by Jeffrey James Olson, Emory University:
Brain Cancer
Brain Neoplasms, Malignant
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs