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CD4 Count And Risk Of Infection In Patients With Brain Tumors


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Infection

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Trial Information

CD4 Count And Risk Of Infection In Patients With Brain Tumors


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.

Inclusion 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
(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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Frequency and severity of decreases in CD4 counts

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

NABTT-0305 CDR0000363636

NCT ID:

NCT00999622

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Infection
  • 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
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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