Clinical trial NCT00999622: Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma
Official title: CD4 Count And Risk Of Infection In Patients With Brain Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
adult pilocytic astrocytoma
adult pineal gland astrocytoma
adult subependymal giant cell astrocytoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: North American Brain Tumor Consortium
First posted: 2009-10-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High grade and low grade

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency and severity of decreases in CD4 counts
timeFrame: 1 year
measure: Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Stuart A. Grossman, MD
role: STUDY_CHAIR
References: