Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases (NCT00424242) | Clinical Trial Compass
CompletedEarly Phase 1
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
United States15 participantsStarted 2007-01
Plain-language summary
RATIONALE: Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Studying samples of cerebrospinal fluid and blood from patients with cancer in the laboratory may help doctors learn how pemetrexed disodium works in the body and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying the side effects and how well pemetrexed disodium works in treating patients with leptomeningeal metastases.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of systemic malignancy (solid tumor or hematologic malignancy) or primary CNS lymphoma with leptomeningeal metastases (LM) as documented by MRI, cerebrospinal fluid, or both
* Patients may have brain metastases in addition to LM
* Patients with clinically significant interstitial fluid with effusion controlled by drainage are eligible
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy \> 2 months
* Creatinine clearance ≥ 45 mL/min
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* Transaminases \< 3.0 times ULN (5 times ULN for hepatic metastasis)
* WBC \> 3,000/mm³
* Neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 10 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* Able to undergo lumbar puncture (i.e., no noncommunicating hydrocephalus or spinal block) or has an Ommaya reservoir in place
* Able to take steroids, cyanocobalamin (vitamin B12), and folic acid
* No other active cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix
* Patients with prior malignancies who are in complete remission and are off all therapy for that malignancy for ≥ 3 years are eligible
* No significant medical or psychiatric illness that would interfere with study compliance
PRIOR CONCURRENT THERAPY:
* More than 2 weeks since prior radiotherapy and recover…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium
Timeframe: Every 6 weeks for assessment while on study.
2
To determine whether there is any anti-tumor activity against LM with Pemetrexed.
Timeframe: Every six weeks.
3
To determine the safety of Pemetrexed in patients with LM.
Timeframe: After every 2 doses approximately 6 weeks
4
To assess the role of serum biomarkers in patients with LM.