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

Infection Clinical Trial

Official title:

CD4 Count And Risk Of Infection In Patients With Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999622
• Other study ID #: NABTT-0305 CDR0000363636
• Secondary ID: U01CA062475NABTT
• Status: Completed
• Phase: N/A
• First received: October 21, 2009
• Last updated: May 24, 2012
• Start date: July 2004

Study information

• Verified date: May 2012
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Communicable Diseases
• Infection
• Nervous System Neoplasms

Intervention

Other:
• laboratory biomarker analysis

• questionnaire administration

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI), North American Brain Tumor Consortium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of decreases in CD4 counts		1 year	Yes
Primary	Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes		1 year	No