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

May 24, 2012 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

CD4 Count And Risk Of Infection In Patients With Brain Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

High grade and low grade

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency and severity of decreases in CD4 counts Time Frame: 1 year	1 year
Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

North American Brain Tumor Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria