Assessment of Systemically Administered Torisel Delivery to Brain Tumors by Intratumoral Microdialysis
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ClinicalTrials.gov Identifier: NCT00949026 |
Recruitment Status :
Withdrawn
(No accrual)
First Posted : July 30, 2009
Last Update Posted : November 21, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Neoplasms | Drug: Temsirolimus (Torisel) | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: Temsirolimus (Torisel)
Dose de-escalation dependent on microdialysis results
Other Name: Torisel |
- Microdialysate torisel concentration [ Time Frame: 24 hours ]
- Toxicity assessment [ Time Frame: 24 hours ]

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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:
- Patients must be at least 18 years of age.
- 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.
- 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).
- Patients must have had prior radiation therapy.
- 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.
- 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.
- 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)
- Patients must be able to provide written informed consent.
- 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.
- Patients must not be allergic to temsirolimus or rapamycin.
Exclusion Criteria:
- 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.
- Patients who are pregnant or breast-feeding.
- Patients without MRI or CT evidence of measurable, contrast-enhancing residual disease are not eligible.
- Patients receiving concurrent chemotherapeutic or investigational agents.

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 ClinicalTrials.gov identifier (NCT number): NCT00949026
United States, Georgia | |
Emory University Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Jeffrey Olson, MD | Emory University Winship Cancer Institute |
Responsible Party: | Jeffrey James Olson, Principal Investigator, Emory University |
ClinicalTrials.gov 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 |
Brain Cancer Brain Neoplasms, Malignant |
Brain Neoplasms Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Sirolimus |
Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |