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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00499798
First received: July 10, 2007
Last updated: September 29, 2014
Last verified: July 2013

July 10, 2007
September 29, 2014
August 2004
June 2009   (final data collection date for primary outcome measure)
assess any changes in standard semen/sperm analysis parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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)
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Complete list of historical versions of study NCT00499798 on ClinicalTrials.gov Archive Site
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Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors
Temozolomide Induced Changes in Semen/Sperm Analysis in Men 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients recieving temozolimide for malignant brain tumor

  • Brain and Central Nervous System Tumors
  • Chemotherapeutic Agent Toxicity
  • Infertility
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patients on temozolimide for brain cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2014
June 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00499798
CDR0000553297, CCCWFU-97404, CCCWFU-BG04-308
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Glenn J. Lesser, MD Comprehensive Cancer Center of Wake Forest University
Principal Investigator: Robert T. Blackwood, PA-S Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP