NCT00424242

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

January 16, 2007

Last Update Submit

September 3, 2021

Conditions

Brain and Central Nervous System TumorsChronic Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisorderMetastatic CancerMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous ConditionSecondary MyelofibrosisUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specifictumors metastatic to brainleptomeningeal metastasesprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomameningeal chronic myelogenous leukemiarelapsing chronic myelogenous leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiaessential thrombocythemiapolycythemia verarecurrent adult acute lymphoblastic leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute myeloid leukemiapreviously treated myelodysplastic syndromessecondary acute myeloid leukemiaacute undifferentiated leukemiamast cell leukemiarecurrent adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaT-cell large granular lymphocyte leukemiaatypical chronic myeloid leukemia, BCR-ABL negativestage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiachronic myelomonocytic leukemiarefractory hairy cell leukemiaprolymphocytic leukemiastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromestage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomaadult grade III lymphomatoid granulomatosisintraocular lymphomapost-transplant lymphoproliferative disorderrefractory multiple myelomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaWaldenstrom macroglobulinemiastage IV adult Burkitt lymphomarecurrent adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomastage IV small lymphocytic lymphomarecurrent small lymphocytic lymphomaadult nasal type extranodal NK/T-cell lymphomaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromessecondary myelodysplastic syndromessecondary myelofibrosisAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomarecurrent adult grade III lymphomatoid granulomatosisstage III multiple myelomaprimary systemic amyloidosisextramedullary plasmacytomamonoclonal gammopathy of undetermined significanceisolated plasmacytoma of bone

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Escalating doses of Pemetrexed

EXPERIMENTAL

Escalating doses of Pemetrexed beginning at 500 mg/m2

Drug: Pemetrexed

Interventions

PemetrexedDRUG

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

Also known as: Alimta, LY231514
Escalating doses of Pemetrexed

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsMyeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersNeoplasm MetastasisMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesPrecancerous ConditionsBrain NeoplasmsMeningeal CarcinomatosisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicThrombocythemia, EssentialPolycythemia VeraPrecursor Cell Lymphoblastic Leukemia-LymphomaCongenital AbnormalitiesLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, AcuteLeukemia, Mast-CellPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Large Granular LymphocyticLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myelomonocytic, ChronicLeukemia, Hairy CellLeukemia, ProlymphocyticMycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousIntraocular LymphomaHodgkin DiseaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyWaldenstrom MacroglobulinemiaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLymphoma, Extranodal NK-T-CellLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseImmunoglobulin Light-chain AmyloidosisMonoclonal Gammopathy of Undetermined Significance

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBrain DiseasesCentral Nervous System DiseasesMeningeal NeoplasmsChronic DiseaseDisease AttributesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, T-CellMyelodysplastic-Myeloproliferative DiseasesLeukemia, B-CellLymphoma, T-CellEye NeoplasmsLymphadenopathyEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesHypergammaglobulinemia

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Jeffrey J. Raizer, MD

    Robert H. Lurie Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 18, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2010

Study Completion

September 1, 2011

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

US(1)