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

NCT01452854 | Terminated Results DMC

• 1 other identifier: UCSF 10-03288
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Grade Glioma

Keywords

LGG; Temozolomide; Temodar; Ovarian Aging; Infertility; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cancer

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).

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• Premenopausal women ages 18-44 newly diagnosed with LGG
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UCSF Center for Reproductive Health

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Dr. Mitchell Rosen
• Organization: UCSF

thomas.remble@ucsfmedctr.org

415-353-7394

Study Officials

• Mitchell Rosen, MD

  UCSF Center for Reproductive Health and Fertility Preservation

  PRINCIPAL INVESTIGATOR

• Michael Prados, MD

  UCSF Department of Neurological Surgery and Helen Diller Comprehensive Cancer Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 17, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 8, 2022
• Results First Posted: August 28, 2014

Record last verified: 2022-07

Locations

US (1)