Clinical trial · Interventional
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
NCT00424242CI-TRIAL-00053755completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Precancerous Condition | — | UNRESOLVED | — |
| Secondary Myelofibrosis | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Escalating doses of Pemetrexed
- description
- Escalating doses of Pemetrexed beginning at 500 mg/m2
- interventionNames
- Drug: Pemetrexed
Primary outcomes (4)
- measure
- Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium
- timeFrame
- Every 6 weeks for assessment while on study.
- description
- Patients will have CSF collected approximately every 6 weeks for assessment while on study.
- measure
- To determine whether there is any anti-tumor activity against LM with Pemetrexed.
- timeFrame
- Every six weeks.
- description
- Patients will have a scan every six weeks to assess tumor response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 recovered * No concurrent radiotherapy * No nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid within 2 days before or after study treatment (5 days for long-acting NSAIDs) * No other concurrent cytotoxic chemotherapy * Concurrent hormonal or biological therapy allowed
References
Publications (0)
Data not yet available
No reference posted for this study.