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

NCT ID: NCT00999622

Last Updated: 2012-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31

Brief 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.

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.

Conditions

Brain and Central Nervous System Tumors; Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

laboratory biomarker analysis

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

Eligibility Criteria

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 (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

North American Brain Tumor Consortium

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart A. Grossman, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other Identifiers

U01CA062475

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NABTT-0305

Identifier Type: -

Identifier Source: secondary_id

NABTT-0305 CDR0000363636

Identifier Type: -

Identifier Source: org_study_id