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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:
ClinicalTrials.gov Identifier:
NCT00499798
First Posted: July 11, 2007
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose

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.


Condition
Brain and Central Nervous System Tumors Chemotherapeutic Agent Toxicity Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temozolomide Induced Changes in Semen/Sperm Analysis in Men With Newly Diagnosed, Progressive or Recurrent Primary Malignant Brain Tumors

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • assess any changes in standard semen/sperm analysis parameters [ Time Frame: 6 months ]
    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)


Enrollment: 16
Study Start Date: August 2004
Study Completion Date: September 2014
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients on temozolimide for brain cancer

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients recieving temozolimide for malignant brain tumor
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499798


Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Glenn J. Lesser, MD Wake Forest University Health Sciences
Principal Investigator: Robert T. Blackwood, PA-S Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00499798     History of Changes
Other Study ID Numbers: CDR0000553297
CCCWFU-97404
CCCWFU-BG04-308
First Submitted: July 10, 2007
First Posted: July 11, 2007
Last Update Posted: May 30, 2017
Last Verified: July 2013

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
infertility
chemotherapeutic agent toxicity
adult anaplastic astrocytoma
adult diffuse astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
adult pilocytic astrocytoma
adult brain stem glioma
adult central nervous system germ cell tumor
adult choroid plexus tumor
adult craniopharyngioma
adult ependymoblastoma
adult medulloblastoma
adult supratentorial primitive neuroectodermal tumor (PNET)
adult anaplastic ependymoma
adult ependymoma
adult myxopapillary ependymoma
adult subependymoma
adult anaplastic meningioma
meningeal melanocytoma
adult meningeal hemangiopericytoma
adult papillary meningioma
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
adult anaplastic oligodendroglioma
adult oligodendroglioma
adult pineoblastoma
adult pineocytoma
adult mixed glioma

Additional relevant MeSH terms:
Infertility
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Genital Diseases, Male
Genital Diseases, Female
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents