Clinical trial NCT01452854: Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide
Official title: Ovarian Aging in Women Newly Diagnosed With Low Grade Glioma Treated With Temozolomide (Temodar®)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Grade Glioma
Keywords: LGG
Temozolomide
Temodar
Ovarian Aging
Infertility
Chemotherapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-10-17
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ovarian Aging (AFC and Hormones)
timeFrame: Every 3 months for 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Center for Reproductive Health
state: California
Study officials:
affiliation: UCSF Center for Reproductive Health and Fertility Preservation
name: Mitchell Rosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Department of Neurological Surgery and Helen Diller Comprehensive Cancer Center
name: Michael Prados, MD
role: STUDY_DIRECTOR
References: