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Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases

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ClinicalTrials.gov Identifier: NCT00424242
Recruitment Status : Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Tracking Information
First Submitted Date  ICMJE January 16, 2007
First Posted Date  ICMJE January 18, 2007
Last Update Posted Date August 19, 2019
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2007)
  • Correlation of cerebrospinal fluid levels with plasma levels of different doses of pemetrexed disodium
  • Pharmacokinetics
  • Progression-free and overall survival
  • Toxicity
  • Response
Change History Complete list of historical versions of study NCT00424242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
Official Title  ICMJE A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: Pemetrexed
Orally beginning at 500 mg/m2 every 3 weeks until disease progression
Other Names:
  • Alimta
  • LY231514
Study Arms  ICMJE Experimental: Escalating doses of Pemetrexed
Escalating doses of Pemetrexed beginning at 500 mg/m2
Intervention: Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2007)
15
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424242
Other Study ID Numbers  ICMJE NU 06C2
STU00004482 ( Other Identifier: Northwestern University IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jeffrey J. Raizer, MD Robert H. Lurie Cancer Center
PRS Account Northwestern University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP