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Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide (OVA-LGG)

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. Identifier: NCT01452854
Recruitment Status : Terminated (Low recruitment, sponsor withdrew funding.)
First Posted : October 17, 2011
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this study is to look at how a chemotherapy treatment (Temozolomide, also called Temodar) affects the process of ovarian aging which is measured by a decline in ovarian follicle count, in patients with Low Grade Glioma (LGG). It is important to know if different patient factors and Temozolomide influence the rate of ovarian aging in women with LGG who have good long-term survival rates. This will allow better counseling about the effects of this particular chemotherapy agent on fertility in women.

Condition or disease
Low Grade Glioma

Detailed Description:

Understanding how Temozolomide influences ovarian aging would be important information for physicians to predict the possibility of infertility (the inability to become pregnant) following recovery from Temozolomide treatment. Physicians would like to provide better individualized recommendations for cancer patients regarding timing of planned treatment and future pregnancy.

We will do this by comparing data from the women being treated for Low Grade Glioma with Temozolomide to a similar group of women who have been unaffected by cancer or cancer treatment.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ovarian Aging in Women Newly Diagnosed With Low Grade Glioma Treated With Temozolomide (Temodar®)
Study Start Date : October 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).

Primary Outcome Measures :
  1. Ovarian Aging (AFC and Hormones) [ Time Frame: Every 3 months for 1 year ]
    Transvaginal Ultrasound will be use to measure Antral Follicle Counts (AFC) and blood will be drawn to measure hormones (FSH, LH, estradiol, estrone, AMH, SHBG, testosterone, and inhibin B).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with temozolomide (Temodar).

Inclusion Criteria:

  • Premenopausal women ages 18-44 newly diagnosed with LGG
  • Patients fulfill the inclusion criteria for UCSF Protocol Number: CC #99102 " A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients with Supratentorial Low Grade Glioma"
  • Patients with histologically proven supratentorial low grade glioma.
  • Patients may or may not have had a surgical resection.
  • Patients must be expected to live the length of study
  • Patients must be able to provide informed consent according to institutional guidelines.

Exclusion Criteria:

  • Prior ovarian resection, unilateral or bilateral oophorectomy, hysterectomy or radiation to pelvic region.
  • Pregnancy or breast feeding.
  • Diagnosis of another malignancy, unless the patient was diagnosed at least 2 years earlier and has been disease-free for at least 6 months following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
  • Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
  • Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
  • Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient.

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 identifier (NCT number): NCT01452854

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United States, California
UCSF Center for Reproductive Health
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Merck Sharp & Dohme Corp.
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Principal Investigator: Mitchell Rosen, MD UCSF Center for Reproductive Health and Fertility Preservation
Study Director: Michael Prados, MD UCSF Department of Neurological Surgery and Helen Diller Comprehensive Cancer Center

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Responsible Party: University of California, San Francisco Identifier: NCT01452854     History of Changes
Other Study ID Numbers: UCSF 10-03288
First Posted: October 17, 2011    Key Record Dates
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014
Last Verified: August 2014

Keywords provided by University of California, San Francisco:
Ovarian Aging

Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents