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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00463008
First received: April 18, 2007
Last updated: June 21, 2013
Last verified: January 2008

April 18, 2007
June 21, 2013
May 2004
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  • Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum [ Designated as safety issue: No ]
  • Safety and efficacy of the microdialysis catheter [ Designated as safety issue: Yes ]
  • Comparison of methotrexate levels in the brain extracelluar fluid and in serum
  • Safety and efficacy of the microdialysis catheter
Complete list of historical versions of study NCT00463008 on ClinicalTrials.gov Archive Site
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Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

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.

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.

Interventional
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Allocation: Non-Randomized
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: methotrexate
  • Other: pharmacological study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00463008
CDR0000346432, NABTT-0302, JHOC-NABTT-0302
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New Approaches to Brain Tumor Therapy
National Cancer Institute (NCI)
Study Chair: Jeffrey J. Olson, MD Winship Cancer Institute of Emory University
Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2008

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