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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00999622
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Stuart A. Grossman, MD
Principal Investigator Affiliation Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Infection
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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