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

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Chemotherapeutic Agent Toxicity Choroid Plexus Neoplasms Craniopharyngioma Ependymoma Genital Diseases Glioblastoma Glioma Glioma, Subependymal Gliosarcoma Infertility Medulloblastoma Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Oligodendroglioma Pinealoma Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

assess any changes in standard semen/sperm analysis parameters

Time frame: 6 months

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)

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2014
First posted: Jul 11, 2007
Registry last updated: May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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