TerminatedNot Applicable

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

Stopped: Low recruitment, sponsor withdrew funding.

United States2 participantsStarted 2011-10

Plain-language 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.

Who can participate

Age range

18 Years – 44 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 on…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ovarian Aging (AFC and Hormones)

Timeframe: Every 3 months for 1 year

Trial details

NCT IDNCT01452854

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-11

Results submitted2014-06-10

View on ClinicalTrials.gov More Low Grade Glioma trials