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

NCT00463008 | Completed

• 3 other identifiers: CDR0000346432NABTT-0302JHOC-NABTT-0302
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

• Safety and efficacy of the microdialysis catheter

Interventions

methotrexate DRUG

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• New Approaches to Brain Tumor Therapy Consortium: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Oligodendroglioma; Glioblastoma; Brain Neoplasms; Gliosarcoma

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey J. Olson, MD

  Emory University

  STUDY CHAIR

• Stuart A. Grossman, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: May 1, 2004
• Study Completion: April 1, 2007
• Last Updated: June 24, 2013

Record last verified: 2008-01