Completed

NCT Number: NCT00999622

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

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Central Nervous System Neoplasms Glioblastoma Glioma Gliosarcoma Infection Infections Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Questionnaire Administration

Other

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

National Cancer Institute (NCI)
North American Brain Tumor Consortium

Registry information

Official study title

CD4 Count And Risk Of Infection In Patients With Brain Tumors

Important dates

Study start: 2004
Primary completion: 2009
First posted: Oct 22, 2009
Registry last updated: May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed