Brain and Central Nervous System TumorsNCT00999622
Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma
An observational study of Brain and Central Nervous System Tumors and Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
RATIONALE: Gathering information over time from laboratory tests of patients with newly diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect of treatment on white blood cell count and the risk of infection. 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, Infection
- What is being tested?
- laboratory biomarker analysis and questionnaire administration
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Aug 2009
- Phase
- Observational
- 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
Study population: High grade and low grade
DISEASE CHARACTERISTICS:
- Histologically confirmed primary malignant brain tumor in 1 of the following groups:
- High grade (grade III or IV) supratentorial glioma receiving antineoplastic treatment and with 1 of the following histologies:
- Anaplastic astrocytoma
- Glioblastoma multiforme (giant cell glioblastoma or gliosarcoma)
- Anaplastic oligodendroma
- Low grade (grade I or II) supratentorial glioma not planning to receive treatment of any kind (including steroids) and with 1 of the following histologies:
- Astrocytoma
- Oligodendroglioma
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for brain tumor except polifeprosan 20 with carmustine implant (Gliadel® wafer)
- No prior cranial radiotherapy or radiotherapy for brain tumor
- No prior immunotherapy or biologic agents for brain tumor, including any of the following:
- Immunotoxins
- Immunoconjugates
- Peptide receptor antagonists
- Interleukins
- Interferons
- Tumor-infiltrating lymphocytes
- Lymphokine-activated killer cell therapy
- Gene therapy
- Antisense therapy
- No prior hormonal therapy for brain tumor
- More than 14 days since prior and no concurrent steroid therapy for patients with low-grade (grade I or II) astrocytoma
- Prior glucocorticoid therapy allowed
About this study
Official title: CD4 Count And Risk Of Infection In Patients With Brain Tumors
RATIONALE: Gathering information over time from laboratory tests of patients with newly diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect of treatment on white blood cell count and the risk of infection.
PURPOSE: This clinical trial is studying blood samples and risk of infection in patients with newly diagnosed malignant supratentorial astrocytoma.
Read the detailed description
OBJECTIVES:
- Determine the frequency and severity of decreases in CD4 counts as a function of therapy in patients with newly diagnosed malignant astrocytoma.
- Determine whether the decrease in CD4 counts is a significant predictor of infections or adverse outcomes in these patients.
OUTLINE: This is a multicenter study.
Patients undergo monthly collection of blood for serial CD4 counts and heme-8 with differential for 1 year for quantitative analysis. Patients also complete a monthly questionnaire about infections and antibiotic use.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 125 patients (100 with high-grade disease and 25 with low-grade disease) will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors, Infection
- Being tested
- laboratory biomarker analysis, questionnaire administration
- Keywords
- infection, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult oligodendroglioma, adult glioblastoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma, adult subependymal giant cell astrocytoma
- Medical subject headings
- Central Nervous System Neoplasms, Infections, Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of decreases in CD4 counts
Measured: 1 year
Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJul 2004
- Primary completionAug 2009
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.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), North American Brain Tumor Consortium
- Responsible party
- Sponsor
- Investigators
- Stuart A. Grossman, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999622
- Sponsor's protocol ID
- NABTT-0305 CDR0000363636
- Other IDs
- U01CA062475, NABTT-0305
- Status last verified
- May 2012
- First submitted
- 21 Oct 2009
- Last updated
- 28 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD4 Count And Risk Of Infection In Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00999622
- Acronym / sponsor ID
- NABTT-0305 CDR0000363636
- Conditions
- Brain and Central Nervous System Tumors, Infection
- Keywords
- infection, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult oligodendroglioma, adult glioblastoma, adult diffuse astrocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), North American Brain Tumor Consortium
- Study start
- Jul 2004
- Primary completion
- Aug 2009 (actual)
- First posted
- 22 Oct 2009 (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: Gathering information over time from laboratory tests of patients with newly diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect of treatment on white blood cell count and the risk of infection.
PURPOSE: This clinical trial is studying blood samples and risk of infection in patients with newly diagnosed malignant supratentorial astrocytoma.
Detailed description
OBJECTIVES:
- Determine the frequency and severity of decreases in CD4 counts as a function of therapy in patients with newly diagnosed malignant astrocytoma.
- Determine whether the decrease in CD4 counts is a significant predictor of infections or adverse outcomes in these patients.
OUTLINE: This is a multicenter study.
Patients undergo monthly collection of blood for serial CD4 counts and heme-8 with differential for 1 year for quantitative analysis. Patients also complete a monthly questionnaire about infections and antibiotic use.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 125 patients (100 with high-grade disease and 25 with low-grade disease) will be accrued for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High grade and low grade
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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Frequency and severity of decreases in CD4 counts
Time frame: 1 year
Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes
Time frame: 1 year
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 28 May 2012.
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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.
Stuart A. Grossman, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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 28 May 2012. 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?
Frequency and severity of decreases in CD4 counts (time frame: 1 year). 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 28 May 2012.