- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00999622
Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency and severity of decreases in CD4 counts
Time Frame: 1 year
|
1 year
|
Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Infections
- Communicable Diseases
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Astrocytoma
Other Study ID Numbers
- NABTT-0305 CDR0000363636
- U01CA062475 (U.S. NIH Grant/Contract)
- NABTT-0305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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