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

Primary Purpose

Brain and Central Nervous System Tumors

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

methotrexate

pharmacological study

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult gliosarcoma, adult giant cell glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Safety and efficacy of the microdialysis catheter

Secondary Outcome Measures

Full Information

NCT ID

NCT00463008

First Posted

April 18, 2007

Last Updated

June 21, 2013

Sponsor

New Approaches to Brain Tumor Therapy Consortium

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00463008

Brief Title

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

Official Title

A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

New Approaches to Brain Tumor Therapy Consortium

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult gliosarcoma, adult giant cell glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Allocation

Non-Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Type

Other

Intervention Name(s)

pharmacological study

Primary Outcome Measure Information:

Title

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

Title

Safety and efficacy of the microdialysis catheter

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey J. Olson, MD

Organizational Affiliation

Emory University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Stuart A. Grossman, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

12. IPD Sharing Statement

Learn more about this trial

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

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