|
|
|
|
|
|
Sponsored by: |
Robert H. Lurie Cancer Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00424242 |
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.
Condition | Intervention |
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Metastatic Cancer Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Secondary Myelofibrosis Unspecified Adult Solid Tumor, Protocol Specific |
Drug: pemetrexed disodium Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
ChemIDplus related topics: | Pemetrexed disodium Pemetrexed Salicylsalicylic acid Sodium salicylate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases |
Estimated Enrollment: | 15 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |||||
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting | ||||
Chicago, Illinois, United States, 60611-3013 | |||||
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Robert H. Lurie Cancer Center |
Study Chair: | Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000522993, NU-06C2, NU-IRB-1398-031, LILLY-NU-06C2 |
First Received: | January 16, 2007 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00424242 |
Health Authority: | Unspecified |
|
|
|
|
|
|