Clinical trial NCT00499798: Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors
Official title: Temozolomide Induced Changes in Semen/Sperm Analysis in Men With Newly Diagnosed, Progressive or Recurrent Primary Malignant Brain Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain and Central Nervous System Tumors
Chemotherapeutic Agent Toxicity
Infertility
Keywords: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-11
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients recieving temozolimide for malignant brain tumor

Brief summary: RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors may help doctors learn about the long-term effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: assess any changes in standard semen/sperm analysis parameters
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Glenn J. Lesser, MD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Robert T. Blackwood, PA-S
role: PRINCIPAL_INVESTIGATOR
References: