Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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CD4 Count And Risk Of Infection In Patients With Brain Tumors

Conditions
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Brain and Central Nervous System Tumors, Infection

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Other: questionnaire administration|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of decreases in CD4 counts |  | 1 year | 
| Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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