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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499798
• Other study ID #: CDR0000553297
• Secondary ID: CCCWFU-97404CCCW
• Status: Completed
• Phase: N/A
• First received: July 10, 2007
• Last updated: May 25, 2017
• Start date: August 2004
• Est. completion date: September 2014

Study information

• Verified date: July 2013
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Brain Neoplasms
• Central Nervous System Neoplasms
• Chemotherapeutic Agent Toxicity
• Infertility
• Nervous System Neoplasms

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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