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Brief Title: 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 ID: NCT00499798
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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: MALE
Healthy Volunteers: No
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Name: Glenn J. Lesser, MD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
Name: Robert T. Blackwood, PA-S
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR