Metastatic Cancer Clinical Trial
Official title:
A Pilot Feasibility, Dose-Escalation Study Using Intracerebral Microdialysis to Assess the Neuropharmacodynamics of Temsirolimus in Patients With Primary or Metastatic Brain Tumors
Verified date | April 2018 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Studying samples of blood and tumor tissue from patients with cancer
in the laboratory may help doctors learn more about how this treatment is used by the body.
PURPOSE: The purpose of this study is to evaluate the feasibility of using a microdialysis
catheter to see what effect temsirolimus has on various biological substances associated with
brain tumors over time.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria Patients must be at least 18 years of age. Patients must have either a primary or metastatic brain tumor(s). Patients must be in need of a surgical debulking or a stereotactic biopsy for the purpose of diagnosis or differentiating between tumor progression and treatment-induced effects following radiation therapy + or - chemotherapy. For patients in cohort 2, treatment with temsirolimus must not be contraindicated. Patients in cohort 2 must not be taking any hepatic enzyme-inducing anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine). Patients who are taking strong CYP3A4 inducers or inhibitors such as clarithromycin, itraconazole, ketoconazole, nefazodone, telithromycin, rifampin, rifabutin, rifampacin, or St. John's Wort must discontinue the medication beginning at least one week prior to surgery and lasting for the duration of the study. The only exception will be dexamethasone which can be used post-operatively as indicated. Patients must have a Karnofsky Performance Status >= 60% or an ECOG/Zubrod score of<= 2. Patients must have recovered from any toxicity of any prior therapy. 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 AST (SGOT) <= 4 times the institutional upper limit of normal, and serum creatinine <=1.5 x the institutional upper limit of normal. Patients must be able to understand and be willing to sign a written informed consent document. The effects of temsirolimus on a developing fetus are unknown. Therefore, female patients of childbearing potential and sexually-active male patients must agree to use an effective method of contraception while participating in this study. Women of childbearing potential must have a negative pregnancy test <=2 weeks prior to registration. Exclusion Criteria Patients must not be planning to receive radiation, other chemotherapy or participate in another clinical trial from the time of surgery until the microdialysis catheters is removed. Patients allergic to temsirolimus, sirolimus (rapamycin), or Dextran. Patients with a coagulopathy, increased susceptibility to infection or bleeding disorders. Patients on anticoagulant drug therapy. Patients with uncontrolled diabetes. Patients who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Female patients who are pregnant or breast-feeding. HIV-positive patients receiving anti-retroviral therapy are excluded from the study due to the possibility of PK interactions with temsirolimus; however, patients will not be routinely screened for HIV. |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of using a microdialysis catheter to assess the neuropharmacodynamics (nPD) of temsirolimus | Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately | ||
Primary | Changes in intracerebral levels of vascular endothelial growth factor (VEGF), interleukin-1ß (IL-1ß), and other cytokines | Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately | ||
Secondary | Relationship between temsirolimus dose and changes in intracerebral levels of VEGF, IL-1ß, and other cytokines | Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately | ||
Secondary | Relationship between the degree of microvascular proliferation and the tensin homologue deleted on chromosome 10 (PTEN) status in tumor tissue | 30 days after placement of the microdialysis catheter. | ||
Secondary | Relationship between changes in intracerebral cytokine levels after treatment with temsirolimus | Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately | ||
Secondary | Compare changes in intracerebral cytokine levels to changes in systemic cytokine levels. | Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately |
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