Brain and Central Nervous System TumorsNCT00463008
Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
A study testing methotrexate and pharmacological study in people with Brain and Central Nervous System Tumors, run by New Approaches to Brain Tumor Therapy Consortium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- methotrexate and pharmacological study
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- methotrexate, pharmacological study
- Keywords
- adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult gliosarcoma, adult giant cell glioblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Astrocytoma, Oligodendroglioma, Glioblastoma, Brain Neoplasms, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum
Safety and efficacy of the microdialysis catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMay 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Approaches to Brain Tumor Therapy Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jeffrey J. Olson, MD, Study chair, Emory UniversityStuart A. Grossman, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463008
- Sponsor's protocol ID
- CDR0000346432
- Other IDs
- NABTT-0302, JHOC-NABTT-0302
- Status last verified
- Jan 2008
- First submitted
- 18 Apr 2007
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter
- ClinicalTrials.gov ID
- NCT00463008
- Acronym / sponsor ID
- CDR0000346432
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- New Approaches to Brain Tumor Therapy ConsortiumUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methotrexate | Drug | – |
| pharmacological study | Other | – |
Primary outcome
Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum
Safety and efficacy of the microdialysis catheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J. Olson, MD study chair
Emory University
Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Questions about this trial
What is this clinical trial studying?
A study testing methotrexate and pharmacological study in people with Brain and Central Nervous System Tumors, run by New Approaches to Brain Tumor Therapy Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.