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| ID | Type | Description | Link |
|---|---|---|---|
| STU00004482 | Other Identifier | Northwestern University IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalating doses of Pemetrexed | Experimental | Escalating doses of Pemetrexed beginning at 500 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | Orally beginning at 500 mg/m2 every 3 weeks until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium | Patients will have CSF collected approximately every 6 weeks for assessment while on study. | Every 6 weeks for assessment while on study. |
| To determine whether there is any anti-tumor activity against LM with Pemetrexed. | Patients will have a scan every six weeks to assess tumor response. | Every six weeks. |
| To determine the safety of Pemetrexed in patients with LM. | Adverse events will be collected every six weeks during patient visits. | After every 2 doses approximately 6 weeks |
| To assess the role of serum biomarkers in patients with LM. | Patients will have a one time blood draw to look at serum biomarkers prior to dose one. | Prior to dose one |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D009362 | Neoplasm Metastasis |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D011230 | Precancerous Conditions |
| D001932 | Brain Neoplasms |
| D055756 | Meningeal Carcinomatosis |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D055728 | Primary Myelofibrosis |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D013920 | Thrombocythemia, Essential |
| D011087 | Polycythemia Vera |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000013 | Congenital Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| D015456 | Leukemia, Biphenotypic, Acute |
| D007946 | Leukemia, Mast-Cell |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D007943 | Leukemia, Hairy Cell |
| D015463 | Leukemia, Prolymphocytic |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D064090 | Intraocular Lymphoma |
| D006689 | Hodgkin Disease |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D008258 | Waldenstrom Macroglobulinemia |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D008577 | Meningeal Neoplasms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D007945 | Leukemia, Lymphoid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D034721 | Mastocytosis, Systemic |
| D008415 | Mastocytosis |
| D000090362 | Mast Cell Activation Disorders |
| D015458 | Leukemia, T-Cell |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015448 | Leukemia, B-Cell |
| D016399 | Lymphoma, T-Cell |
| D005134 | Eye Neoplasms |
| D000072281 | Lymphadenopathy |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006942 | Hypergammaglobulinemia |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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