Low Grade Glioma
Conditions
Keywords
LGG, Temozolomide, Temodar, Ovarian Aging, Infertility, Chemotherapy
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian Aging (AFC and Hormones) | Every 3 months for 1 year | 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). |
Countries
United States
Participant flow
Recruitment details
Low recruitment necessitated the closing of the study. No results available.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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).
Time frame: Every 3 months for 1 year
Population: Data collection was terminated and analyses were not performed due to low enrollment