NCT00999622

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

5.1 years

First QC Date

October 21, 2009

Last Update Submit

May 24, 2012

Conditions

Brain and Central Nervous System TumorsInfection

Keywords

infectionadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult giant cell glioblastomaadult gliosarcomaadult oligodendrogliomaadult glioblastomaadult diffuse astrocytomaadult pilocytic astrocytomaadult pineal gland astrocytomaadult subependymal giant cell astrocytoma

Outcome Measures

Primary Outcomes (2)

  • Frequency and severity of decreases in CD4 counts

    1 year

  • Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes

    1 year

Interventions

laboratory biomarker analysisOTHER
questionnaire administrationOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

High grade and low grade

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Central Nervous System NeoplasmsInfectionsAstrocytomaOligodendrogliomaGlioblastomaGliosarcoma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Stuart A. Grossman, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

July 1, 2004

Primary Completion

August 1, 2009

Last Updated

May 28, 2012

Record last verified: 2012-05