Infection Clinical Trial
Official title:
CD4 Count And Risk Of Infection In Patients With Brain Tumors
Verified date | May 2012 |
Source | Sidney Kimmel Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 (GliadelĀ® 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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center | National Cancer Institute (NCI), North American Brain Tumor Consortium |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and severity of decreases in CD4 counts | 1 year | Yes | |
Primary | Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes | 1 year | No |
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