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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Comprehensive Cancer Center of Wake Forest University

ClinicalTrials.gov Identifier:

NCT00499798

First received: July 10, 2007

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 10, 2007

Last Updated Date

June 28, 2012

Start Date ^ICMJE

August 2004

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00499798 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients recieving temozolimide for malignant brain tumor

Condition ^ICMJE

Brain and Central Nervous System Tumors
Chemotherapeutic Agent Toxicity
Infertility

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

patients on temozolimide for brain cancer

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00499798

Other Study ID Numbers ^ICMJE

CDR0000553297, CCCWFU-97404, CCCWFU-BG04-308

Has Data Monitoring Committee

Responsible Party

Comprehensive Cancer Center of Wake Forest University

Study Sponsor ^ICMJE

Comprehensive Cancer Center of Wake Forest University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

Comprehensive Cancer Center of Wake Forest University

Verification Date

June 2012

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

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