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

This study has been completed.
Sponsor:
Collaborators:
North American Brain Tumor Consortium
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00999622
First received: October 21, 2009
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Infection
Other: laboratory biomarker analysis
Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: CD4 Count And Risk Of Infection In Patients With Brain Tumors

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Frequency and severity of decreases in CD4 counts [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: July 2004
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

High grade and low grade

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999622

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
North American Brain Tumor Consortium
Investigators
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00999622     History of Changes
Other Study ID Numbers: NABTT-0305 CDR0000363636, U01CA062475, NABTT-0305
Study First Received: October 21, 2009
Last Updated: May 24, 2012
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Astrocytoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014