Pharmacokinetics of Systemic Anti-Cancer Therapies in the Cerebrospinal Fluid (CSF) of Patients With Advanced Cancer

Stopped early

Conditions studied: Metastatic Cancer Patients on an Anti-cancer Therapy, Advanced Cancer, Brain Metastasis

In brief

This clinical trial is being done to learn more about how different types of cancer treatments affect cancer cells when they spread to the brain. Many cancer treatments are not able to make their way into the brain or into spinal fluid of the central nervous system. This is because they cannot cross what is called the "blood-brain barrier" or "BBB". The BBB is like a protective shield that only allows certain materials pass through to reach the brain but not others. This study is being initiated to help researchers learn more about what types of cancer treatments make it through the BBB to attack cancer cells within the brain, and what treatments do not make it through the BBB. Learning more about this may help future researchers develop more effective cancer drugs that better fight cancer cells that have spread to the brain.

Key facts

Study ID

NCT02580045

Run by

Duke University

People needed

3

Starts

2016-04-01

Expected to finish

2018-02-22

Last updated by the study team

2018-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic cancer patients on systemic anti-cancer therapy (chemotherapy, endocrine therapy, HER2 targeted therapy, immune therapy).
• Patients must be able to have a lumbar puncture within 2 half-lives of the last dose of systemic therapy.
• Patients undergoing an LP for any reason with known advanced cancer on systemic anti-cancer therapy are eligible.
• Patients with new or previously treated brain metastases are eligible.
• Patients may have received prior stereotactic radiosurgery to the brain and/or whole brain radiation.
• No limitations on prior systemic or intrathecal therapies.
• There are no restrictions on systemic therapy at enrollment.
• 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.
• Age > 18 years
• Patients must have the ability to give informed consent.
• Patients must have a signed informed consent form prior to enrollment on study.

You may not qualify if…

• No history of lumbar surgery or other pre-existing spinal conditions that would preclude a safe, reliable lumbar puncture.
• Patients should have no significant psychiatric illness or medical illness that would preclude the ability to comply with the protocol.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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