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Ovarian Aging in Women Newly Diagnosed With Low Grade Glioma Treated With Temozolomide (TemodarĀ®)

18 Years
44 Years
Open (Enrolling)
Low Grade Glioma

Thank you

Trial Information

Ovarian Aging in Women Newly Diagnosed With Low Grade Glioma Treated With Temozolomide (TemodarĀ®)

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

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

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Ovarian Aging (AFC and Hormones)

Outcome Description:

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). Hormones:

Outcome Time Frame:

Every 3 months for 1 year

Safety Issue:


Principal Investigator

Mitchell Rosen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSF Center for Reproductive Health and Fertility Preservation


United States: Institutional Review Board

Study ID:

UCSF 10-03288



Start Date:

October 2011

Completion Date:

November 2014

Related Keywords:

  • Low Grade Glioma
  • LGG
  • Temozolomide
  • Temodar
  • Ovarian Aging
  • Infertility
  • Chemotherapy
  • Glioma



UCSF Center for Reproductive HealthSan Francisco, California  94115