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NCT Number: NCT00424242

Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Brain Diseases Brain Neoplasms Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Central Nervous System Diseases Central Nervous System Neoplasms Chronic Disease Chronic Myeloproliferative Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Eye Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Intraocular Lymphoma Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Mast-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorder Lymphoproliferative Disorders Mast Cell Activation Disorders Mastocytosis Mastocytosis, Systemic Meningeal Carcinomatosis Meningeal Neoplasms Metabolic Diseases Metastatic Cancer Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Polycythemia Vera Precancerous Condition Precancerous Conditions Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Secondary Myelofibrosis Sezary Syndrome Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

Orally beginning at 500 mg/m2 every 3 weeks until disease progression

Other names: Alimta, LY231514

Primary outcomes

  1. Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium

    Time frame: Every 6 weeks for assessment while on study.

    Patients will have CSF collected approximately every 6 weeks for assessment while on study.

  2. To determine whether there is any anti-tumor activity against LM with Pemetrexed.

    Time frame: Every six weeks.

    Patients will have a scan every six weeks to assess tumor response.

  3. To determine the safety of Pemetrexed in patients with LM.

    Time frame: After every 2 doses approximately 6 weeks

    Adverse events will be collected every six weeks during patient visits.

  4. To assess the role of serum biomarkers in patients with LM.

    Time frame: Prior to dose one

    Patients will have a one time blood draw to look at serum biomarkers prior to dose one.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Jan 18, 2007
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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