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

Low Grade Glioma Clinical Trial

— OVA-LGG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01452854
• Other study ID #: UCSF 10-03288
• Status: Terminated
• Start date: October 2011
• Est. completion date: November 2013

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• Low Grade Glioma

Locations

Country	Name	City	State
United States	UCSF Center for Reproductive Health	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian Aging (AFC and Hormones)	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).	Every 3 months for 1 year