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|NCT02580045 : Pharmacokinetics of Systemic Anti-Cancer Therapies in the Cerebrospinal Fluid (CSF) of Patients With Advanced Cancer|
|Ages||Min: 18 Years Max: N/A|
1. Metastatic cancer patients on systemic anti-cancer therapy (chemotherapy, endocrine
therapy, HER2 targeted therapy, immune therapy).
2. Patients must be able to have a lumbar puncture within 2 half-lives of the last dose
of systemic therapy.
3. Patients undergoing an LP for any reason with known advanced cancer on systemic
anti-cancer therapy are eligible.
4. Patients with new or previously treated brain metastases are eligible.
5. Patients may have received prior stereotactic radiosurgery to the brain and/or whole
6. No limitations on prior systemic or intrathecal therapies.
7. There are no restrictions on systemic therapy at enrollment.
8. Laboratory criteria: normal renal function: creatinine < 1.5 x upper limit of normal
(ULN)), liver function: bilirubin < 1.5 x ULN, transaminases < 2 x ULN, except in
known hepatic disease, wherein may be < 5 x ULN, and blood counts: WBC ? 2.0,
Neutrophils ?1500, platelets ?100,000, Hemoglobin ? 10.
9. Age > 18 years
10. Patients must have the ability to give informed consent.
11. Patients must have a signed informed consent form prior to enrollment on study.
1. No history of lumbar surgery or other pre-existing spinal conditions that would
preclude a safe, reliable lumbar puncture.
2. Patients should have no significant psychiatric illness or medical illness that would
preclude the ability to comply with the protocol.
|Links||Permanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02580045
| Link to official Clinicaltrials.gov listing
Facility: Duke University Medical Center
Kimberly Blackwell, MD
Kim Riley Phone: 919-660-1278
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