Clinical trial · Observational

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

CD4 Count And Risk Of Infection In Patients With Brain Tumors

NCT00999622CI-TRIAL-00006997completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Infection	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
laboratory biomarker analysis	Other	—	UNRESOLVED
questionnaire administration	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (2)

measure
Frequency and severity of decreases in CD4 counts
timeFrame
1 year
measure
Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes
timeFrame
1 year

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 1, 2004
Primary completion: Aug 1, 2009
Completion: —
First posted: Oct 22, 2009
Last update posted: May 28, 2012
Enrollment: 104 (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins OTHER
Collaborators: National Cancer Institute (NCI); North American Brain Tumor Consortium
Keywords: infection, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult oligodendroglioma, adult glioblastoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma, adult subependymal giant cell astrocytoma

Data updated 22 days agoSource updated May 28, 2012source: clinicaltrials

Locations

Locations by country (0)

No location posted.

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.