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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 30, 2017

Status Verified

July 1, 2013

Enrollment Period

4.8 years

First QC Date

July 10, 2007

Last Update Submit

May 25, 2017

Conditions

Brain and Central Nervous System TumorsChemotherapeutic Agent ToxicityInfertility

Keywords

infertilitychemotherapeutic agent toxicityadult anaplastic astrocytomaadult diffuse astrocytomaadult giant cell glioblastomaadult gliosarcomaadult pilocytic astrocytomaadult brain stem gliomaadult central nervous system germ cell tumoradult choroid plexus tumoradult craniopharyngiomaadult ependymoblastomaadult medulloblastomaadult supratentorial primitive neuroectodermal tumor (PNET)adult anaplastic ependymomaadult ependymomaadult myxopapillary ependymomaadult subependymomaadult anaplastic meningiomameningeal melanocytomaadult meningeal hemangiopericytomaadult papillary meningiomaadult grade I meningiomaadult grade II meningiomaadult grade III meningiomaadult anaplastic oligodendrogliomaadult oligodendrogliomaadult pineoblastomaadult pineocytomaadult mixed gliomarecurrent adult brain tumoradult subependymal giant cell astrocytoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients on temozolimide for brain cancer

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients recieving temozolimide for malignant brain tumor

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsInfertilityAstrocytomaGlioblastomaGliosarcomaChoroid Plexus NeoplasmsCraniopharyngiomaNeuroectodermal Tumors, PrimitiveMedulloblastomaEpendymomaGlioma, SubependymalMeningiomaOligodendrogliomaPinealomaGliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGenital DiseasesUrogenital DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCerebral Ventricle NeoplasmsBrain DiseasesCentral Nervous System DiseasesNeoplasms, Vascular TissueMeningeal Neoplasms

Study Officials

  • Glenn J. Lesser, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

  • Robert T. Blackwood, PA-S

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

August 1, 2004

Primary Completion

June 1, 2009

Study Completion

September 1, 2014

Last Updated

May 30, 2017

Record last verified: 2013-07

Locations

US(1)