Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain and Central Nervous System Tumors, Chemotherapeutic Agent Toxicity, Infertility

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients on temozolimide for brain cancer<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess any changes in standard semen/sperm analysis parameters | 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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