View Clinical Trial (Medical Research Study)
Assessment of Systemically Administered Torisel Delivery to Brain Tumors by Intratumoral Microdialysis - NCT00949026-30322(Clinical Trial 304066)
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Atlanta |
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State:
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GA |
| Zip Code: |
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30322 |
| Conditions: |
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Brain Neoplasms |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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July 12, 2010 |
Modifications to
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above to view all information about this clinical trial. |
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