NCT00424242

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * Determine the cerebrospinal fluid (CSF):plasma ratio of pemetrexed disodium at different IV dose levels in patients with leptomeningeal metastases. * Determine the safety of this drug in these patients. * Determine the antitumor activity of this drug in these patients. * Assess the role of CSF vascular endothelial growth factor and YKL 40 as markers of response and/or prognosis in these patients. OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lumbar puncture and blood collection prior to therapy and 30-60 minutes after the first dose of pemetrexed disodium for pharmacological studies. Patients with Ommaya reservoirs undergo cerebrospinal fluid (CSF) collection at baseline and 0.25, 0.50, 1, 2, 4, 6 and 8.0 hours after pemetrexed disodium administration. CSF is then obtained once during each subsequent course of study treatment. CSF and blood are also evaluated for YKL 40 and vascular endothelial growth factor. After completion of study therapy, patients are followed every 2-3 months. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors
• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Metastatic Cancer
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Precancerous Condition
• Secondary Myelofibrosis
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	Pemetrexed	Orally beginning at 500 mg/m2 every 3 weeks until disease progression

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-01-01
• Completion: 2011-09-01
• First posted: 2007-01-18
• Last updated: 2021-09-08

Locations

1 site across 1 country: United States