Metastatic Cancer Patients on an Anti-cancer TherapyNCT02580045
Pharmacokinetics of Systemic Anti-Cancer Therapies in the Cerebrospinal Fluid (CSF) of Patients With Advanced Cancer
An observational study of Metastatic Cancer Patients on an Anti-cancer Therapy and Advanced Cancer, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer Patients on an Anti-cancer Therapy, Advanced Cancer, Brain Metastasis
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 22 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic or advanced cancer patients on systemic anti-cancer therapy including chemotherapy, endocrine therapy, HER2-targeted therapy, and immune therapy.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: CSF Pharmacokinetics of Systemic Anti-Cancer Therapies in Patients With Advanced Cancer
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.
Read the detailed description
Very little is known about the penetration of systemic therapies through the normal blood brain barrier and the ways in which a brain metastasis or radiation would impact the permeability of the blood brain barrier. This study would be one of the first to examine the concentrations of systemic cancer therapies in the cerebrospinal fluid (CSF) with matched serum samples. Additionally, the concentration of these therapies in brain metastasis surgical specimens would be of particular interest to correlate with serum and CSF levels, length of time on therapy, and latency to developing brain metastases in future studies.
As participants in this study, patients scheduled for a lumbar puncture per their standard of care treatment will be subject to a withdrawal of 15cc's of cerebrospinal fluid for pharmacokinetic analysis. They will also have a blood draw of 5mL within 2 hours of the lumbar puncture for serum pharmacokinetics. If the patient is eligible for and elects to proceed with surgical resection of a brain metastasis, optional CSF and serum samples would be drawn at the time of resection.
- Keywords
- metastatic cancer, lumbar puncture, advanced cancer, brain metastases, chemotherapy, endocrine therapy, HER2 targeted therapy, immune therapy, anti-cancer therapy, blood brain barrier, pharmacokinetics, Duke University, brain metastasis
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of drug metabolites of systemic anti-cancer therapies in the cerebrospinal fluid
CSF pharmacokinetics of systemic anti-cancer therapies, as measured by the concentration of their metabolites in the cerebrospinal fluid, will be obtained via lumbar puncture. The lumbar puncture will take place within 2 half-lives of the last dose of systemic therapy. Because a wide variety of anti-cancer therapies will be studied in this trial, there is significant variability in the half-lives of these therapies. Some will take place 2-24 hours after the last dose of systemic therapy. Some will take place 1-6 days after the last dose of systemic therapy. Some will take place 1-3 weeks after the last dose of systemic therapy. The time of the lumbar puncture procedure will depend greatly on the identity of the systemic therapy with which the subject is being treated. In patients undergoing surgical resection of a brain metastasis, an additional CSF sample is optional.
Measured: up to 3 weeks
Ratio of serum to CSF concentration of systemic anti-cancer therapies as measured by concentration of drug metabolites in serum and in CSF
CSF and serum pharmacokinetics of systemic anti-cancer therapies, as measured by the concentration of their metabolites, will be obtained via lumbar puncture and blood draw, respectively. The lumbar puncture and blood draw will take place together within 2 half-lives of the last dose of systemic therapy. Because a wide variety of anti-cancer therapies will be studied in this trial, there is significant variability in the half-lives of these therapies. Some will take place 2-24 hours after the last dose of systemic therapy. Some will take place 1-6 days after the last dose. Some will take place 1-3 weeks after the last dose. The time of the lumbar puncture procedure will depend greatly on the identity of the systemic therapy with which the subject is being treated. In patients undergoing surgical resection of a brain metastasis, an additional matched CSF and serum sample is optional.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start1 Apr 2016
- Primary completion22 Feb 2018
- Study completion22 Feb 2018
Why it stopped: Inadequate Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Cancer Patients on an Anti-cancer TherapyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly L Blackwell, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580045
- Sponsor's protocol ID
- Pro00062142
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSF Pharmacokinetics of Systemic Anti-Cancer Therapies in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02580045
- Acronym / sponsor ID
- Pro00062142
- Keywords
- metastatic cancer, lumbar puncture, advanced cancer, brain metastases, chemotherapy, endocrine therapy, HER2 targeted therapy, immune therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate Accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Very little is known about the penetration of systemic therapies through the normal blood brain barrier and the ways in which a brain metastasis or radiation would impact the permeability of the blood brain barrier. This study would be one of the first to examine the concentrations of systemic cancer therapies in the cerebrospinal fluid (CSF) with matched serum samples. Additionally, the concentration of these therapies in brain metastasis surgical specimens would be of particular interest to correlate with serum and CSF levels, length of time on therapy, and latency to developing brain metastases in future studies.
As participants in this study, patients scheduled for a lumbar puncture per their standard of care treatment will be subject to a withdrawal of 15cc's of cerebrospinal fluid for pharmacokinetic analysis. They will also have a blood draw of 5mL within 2 hours of the lumbar puncture for serum pharmacokinetics. If the patient is eligible for and elects to proceed with surgical resection of a brain metastasis, optional CSF and serum samples would be drawn at the time of resection.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic or advanced cancer patients on systemic anti-cancer therapy including chemotherapy, endocrine therapy, HER2-targeted therapy, and immune therapy.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concentration of drug metabolites of systemic anti-cancer therapies in the cerebrospinal fluid
Time frame: up to 3 weeks
CSF pharmacokinetics of systemic anti-cancer therapies, as measured by the concentration of their metabolites in the cerebrospinal fluid, will be obtained via lumbar puncture. The lumbar puncture will take place within 2 half-lives of the last dose of systemic therapy. Because a wide variety of anti-cancer therapies will be studied in this trial, there is significant variability in the half-lives of these therapies. Some will take place 2-24 hours after the last dose of systemic therapy. Some will take place 1-6 days after the last dose of systemic therapy. Some will take place 1-3 weeks after the last dose of systemic therapy. The time of the lumbar puncture procedure will depend greatly on the identity of the systemic therapy with which the subject is being treated. In patients undergoing surgical resection of a brain metastasis, an additional CSF sample is optional.
Ratio of serum to CSF concentration of systemic anti-cancer therapies as measured by concentration of drug metabolites in serum and in CSF
Time frame: up to 3 weeks
CSF and serum pharmacokinetics of systemic anti-cancer therapies, as measured by the concentration of their metabolites, will be obtained via lumbar puncture and blood draw, respectively. The lumbar puncture and blood draw will take place together within 2 half-lives of the last dose of systemic therapy. Because a wide variety of anti-cancer therapies will be studied in this trial, there is significant variability in the half-lives of these therapies. Some will take place 2-24 hours after the last dose of systemic therapy. Some will take place 1-6 days after the last dose. Some will take place 1-3 weeks after the last dose. The time of the lumbar puncture procedure will depend greatly on the identity of the systemic therapy with which the subject is being treated. In patients undergoing surgical resection of a brain metastasis, an additional matched CSF and serum sample is optional.
Results and safety
The study was stopped early (reason given: Inadequate Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly L Blackwell, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer Patients on an Anti-cancer Therapy and Advanced Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of drug metabolites of systemic anti-cancer therapies in the cerebrospinal fluid (time frame: up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.