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Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00463008
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 18, 2007
First Posted Date  ICMJE April 19, 2007
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum
  • Safety and efficacy of the microdialysis catheter
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2007)
  • Comparison of methotrexate levels in the brain extracelluar fluid and in serum
  • Safety and efficacy of the microdialysis catheter
Change History
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 Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
Official Title  ICMJE A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter
Brief Summary

RATIONALE: Collecting fluid from a brain tumor using a small catheter may help doctors learn how much methotrexate gets into the tumor to kill the tumor cells. It may also help doctors learn how methotrexate works in the brain and in the rest of the body.

PURPOSE: This clinical trial is studying how much methotrexate gets into the brain tumor by collecting fluid directly from the tumor through a small catheter in patients undergoing stereotactic biopsy for recurrent high-grade glioma.

Detailed Description

OBJECTIVES:

  • Determine the feasibility of using microdialysis to study distribution of systemically administered methotrexate in the interstitial fluid within a tumor in patients undergoing stereotactic biopsy for recurrent high-grade gliomas.
  • Determine the systemic and intratumoral pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients have an intratumoral microdialysis catheter placed while undergoing stereotactic biopsy. Between 18-32 hours after placement of catheter, patients receive methotrexate IV over 4 hours. Microdialysis perfusate and blood specimens are collected before, during, and for 24 hours after methotrexate administration.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: methotrexate
  • Other: pharmacological study
Study Arms  ICMJE Not Provided
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 Completed
Estimated Enrollment  ICMJE
 (submitted: April 18, 2007)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed supratentorial grade III or IV astrocytoma of 1 of the following subtypes:

    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Glioblastoma multiforme
  • Measurable, contrast-enhancing, residual disease by MRI or CT scan
  • Undergoing stereotactic biopsy for confirmation of tumor progression or differentiation of tumor progression from treatment-induced effects

    • Patients with prior low-grade glioma that progressed after prior radiotherapy with or without chemotherapy and in need of stereotactic biopsy to confirm high-grade glioma are eligible
  • Must have received prior radiotherapy with or without chemotherapy
  • Planning to continue methotrexate therapy after participation on this study
  • No ascites or pleural effusions

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 2.0 mg/dL
  • SGOT ≤ 4 times upper limit of normal
  • Creatinine ≤ 2 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ
  • Able to achieve hydration necessary for the use of methotrexate
  • Mini mental state exam score at least 15
  • No allergy to methotrexate
  • No other concurrent infection or medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 3 months since prior radiotherapy
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 1 week since prior salicylates, nonsteroidal anti-inflammatory drugs, or sulfonamides
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent chemotherapeutic agents
  • No other concurrent investigational agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00463008
Other Study ID Numbers  ICMJE CDR0000346432
NABTT-0302
JHOC-NABTT-0302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE New Approaches to Brain Tumor Therapy Consortium
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jeffrey J. Olson, MD Emory University
Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account National Cancer Institute (NCI)
Verification Date January 2008

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