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Temozolomide Induced Changes in Semen/Sperm Analysis in Men With Newly Diagnosed, Progressive or Recurrent Primary Malignant Brain Tumors


N/A
18 Years
60 Years
Open (Enrolling)
Male
Brain and Central Nervous System Tumors, Chemotherapeutic Agent Toxicity, Infertility

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Trial Information

Temozolomide Induced Changes in Semen/Sperm Analysis in Men With Newly Diagnosed, Progressive or Recurrent Primary Malignant Brain Tumors


OBJECTIVES:

Primary

- Assess if temozolomide induces any changes in standard semen or sperm analysis
parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile
count, motility, presence of round cells, agglutination, and morphology) in patients
with newly diagnosed, recurrent, or progressive primary malignant brain tumors.

OUTLINE: This is a pilot study.

During treatment with temozolomide, patients undergo semen or sperm sample collection at
baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume,
viscosity, pH, forward progression, total count, total motile count, motility, presence of
round cells, agglutination, and morphology.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary malignant brain tumor

- Newly diagnosed, progressive, or recurrent disease

- May have received prior radiotherapy with or without chemotherapy

- Scheduled to begin single-agent temozolomide chemotherapy

- Must be able to ejaculate

- Must abstain from ejaculating (e.g., not have sex or masturbate) for 2-7 days
prior to study

- No known abnormal sperm motility and/or morphology

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

assess any changes in standard semen/sperm analysis parameters

Outcome Description:

assess if Temozolomide induces any changes in standard semen/sperm analysis parameters (volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Glenn J. Lesser, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000553297

NCT ID:

NCT00499798

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Chemotherapeutic Agent Toxicity
  • Infertility
  • infertility
  • chemotherapeutic agent toxicity
  • adult anaplastic astrocytoma
  • adult diffuse astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pilocytic astrocytoma
  • adult brain stem glioma
  • adult central nervous system germ cell tumor
  • adult choroid plexus tumor
  • adult craniopharyngioma
  • adult ependymoblastoma
  • adult medulloblastoma
  • adult supratentorial primitive neuroectodermal tumor (PNET)
  • adult anaplastic ependymoma
  • adult ependymoma
  • adult myxopapillary ependymoma
  • adult subependymoma
  • adult anaplastic meningioma
  • meningeal melanocytoma
  • adult meningeal hemangiopericytoma
  • adult papillary meningioma
  • adult grade I meningioma
  • adult grade II meningioma
  • adult grade III meningioma
  • adult anaplastic oligodendroglioma
  • adult oligodendroglioma
  • adult pineoblastoma
  • adult pineocytoma
  • adult mixed glioma
  • recurrent adult brain tumor
  • adult subependymal giant cell astrocytoma
  • Brain Neoplasms
  • Infertility
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096