Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
National Comprehensive Cancer Network
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed carcinoma of the prostate. Histologic evidence may be confirmed through local or metastatic biopsy review
Radiographic Evidence of metastatic disease
Evidence of disease progression despite castrate levels of testosterone.
A circulating timor cell count using FDA approved CellSearch methodology of ≥ 10 per 7.5 cc whole blood, drawn within 4 weeks of study registration
Serum PSA greater than or equal to 2ng/dl at registration
At least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Grade less than or equal to 1
Age ≥ 18 years
Adequate laboratory parameters
Karnofsky Performance Status ≥ 60
Life expectancy of at least 3 months
You may not be if
History of or active central nervous system metastases
The use of cytotoxic, biologic, or hormonal therapies within 4 weeks of study entry.
Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the screening visit
Have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
Presence of non-healing wound or ucer
Grade ≥ 3 hemorrhage in the past month to study entry
Hypertension with systolic blood pressure of ≥ 180 mmHg and/or diastolic pressure ≥ 100 mmHg (Anti-hypertensive medications are permitted)
Subjects with Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction \<50% or a recent (within 12 months) cardiovascular event.
Anticoagulation with warfarin
Diabetes mellitus with glycosylated hemoglobin A1c ≥ 10% despite therapy
History of interstitial pneumonitis
Subjects with active autoimmune disorder(s) being treated with immunosuppressive agents within 4 weeks prior to screening visit
Subjects receiving immunosuppressive agents and those with chronic viral/bacterial/fungal illnesses. Replacement doses of corticosteroids are permitted.
Active infection(s), active antimicrobial therapy or serious intercurrent illness.
History of other prior malignancy in past 5 years, other than basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in sity, localized prostate cancer, or superficial bladder cancer.
Agreement to use medically acceptable contraceptive methods while on study and for 3 months after the last dose of temsirolimus.
Any other major medical or psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications.
Known hypersensitivity to any of the components in the temsirolimus infusion or other medical reasons for not being able to receive adequate premedication.
Corrected QT interval on baseline EKG of \>500 milliseconds
the use of agents that significantly prolong the Corrected QT interval and who are unable to stop medications prior to study initiation.
Prior exposure to an Mammalian Target of Rapamycin (mTOR) inhibitor
Presence of nephrotic syndrome as determined by clinical evaluation of 24 hour urine.
Clareo Health | Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer
