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

• ClinicalTrials.gov Identifier: NCT00949026
• Recruitment Status: Withdrawn
• First Posted: July 30, 2009
• Last Update Posted: November 21, 2013
• Sponsor: Emory University
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Jeffrey James Olson, Emory University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Toxicity assessment [ Time Frame: 24 hours ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Jeffrey Olson, MD; Emory University Winship Cancer Institute

More Information

• 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
• 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:

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