Status:
COMPLETED
Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
Lead Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
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 metho...
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 stereota...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00463008
Start Date
May 1 2004
End Date
April 1 2007
Last Update
June 24 2013
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