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
  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
Other: pharmacological study

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

Resource links provided by NLM:


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
Study Completion Date: April 2007
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
New Approaches to Brain Tumor Therapy Consortium
Investigators
Study Chair: Jeffrey J. Olson, MD Winship Cancer Institute of Emory University
Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00463008     History of Changes
Other Study ID Numbers: CDR0000346432, NABTT-0302, JHOC-NABTT-0302
Study First Received: April 18, 2007
Last Updated: June 21, 2013
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

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

ClinicalTrials.gov processed this record on September 18, 2014