Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Treatment Completed 18 and over NCI NABTT-0302 JHOC-NABTT-0302, NCT00463008

Objectives

1. 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.
2. Determine the systemic and intratumoral pharmacokinetics of this drug in these patients.

Entry 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

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

Patient Characteristics:

• Karnofsky performance status 60-100%
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum
Safety and efficacy of the microdialysis catheter

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.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Jeffrey Olson, MD, Protocol chair		Ph: 404-778-5770; 888-946-7447
Stuart Grossman, MD, Protocol co-chair		Ph: 410-955-8837 Email: Grossman@jhmi.edu

Registry Information
Official Title		A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter
Trial Start Date		2004-05-06
Registered in ClinicalTrials.gov		NCT00463008
Date Submitted to PDQ		2003-11-12
Information Last Verified		2008-01-18
NCI Grant/Contract Number		CA062475

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