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Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
This study has been completed.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00463008
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Drug: methotrexate
Procedure: pharmacological study

MedlinePlus related topics: Brain Cancer Cancer
Drug Information available for: Methotrexate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463008

Sponsors and Collaborators
Investigators
Study Chair: Jeffrey J. Olson, MD Emory University
Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000346432, NABTT-0302, JHOC-NABTT-0302
Study First Received: April 18, 2007
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00463008  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
recurrent adult brain tumor
adult gliosarcoma
adult giant cell glioblastoma

Study placed in the following topic categories:
Folic Acid
Brain Neoplasms
Glioblastoma
Astrocytoma
Methotrexate
Oligodendroglioma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009