Status:
TERMINATED
Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Low Grade Glioma
Eligibility:
FEMALE
18-44 years
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, ...
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 fr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01452854
Start Date
October 1 2011
End Date
November 1 2013
Last Update
July 8 2022
Active Locations (1)
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1
UCSF Center for Reproductive Health
San Francisco, California, United States, 94115