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A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter


- 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

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.

Inclusion Criteria


- 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


- 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


- 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

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

- No concurrent chemotherapeutic agents

- No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum

Safety Issue:


Principal Investigator

Jeffrey J. Olson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University


United States: Federal Government

Study ID:




Start Date:

May 2004

Completion Date:

April 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult glioblastoma
  • recurrent adult brain tumor
  • adult gliosarcoma
  • adult giant cell glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms