Clinical trial · Observational
Pharmacokinetics of Systemic Anti-Cancer Therapies in the Cerebrospinal Fluid (CSF) of Patients With Advanced Cancer
CSF Pharmacokinetics of Systemic Anti-Cancer Therapies in Patients With Advanced Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate Accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Brain Metastasis | — | UNRESOLVED | — |
| Metastatic Cancer Patients on an Anti-cancer Therapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The concentration of drug metabolites of systemic anti-cancer therapies in the cerebrospinal fluid
- timeFrame
- up to 3 weeks
- description
- 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.
- measure
- Ratio of serum to CSF concentration of systemic anti-cancer therapies as measured by concentration of drug metabolites in serum and in CSF
- timeFrame
- up to 3 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 brain radiation. 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. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available