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

Wake Forest University (WFU)

Status: Completed

Conditions: Chemotherapeutic Agent Toxicity; Infertility; Brain and Central Nervous System Tumors

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00499798

CDR0000553297

CCCWFU-97404

CCCWFU-BG04-308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

16 participants in 1 patient group

patients on temozolimide for brain cancer