OVA-LGG: Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Premenopausal women ages 18-44 newly diagnosed with LGG
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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"
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Patients with histologically proven supratentorial low grade glioma.
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Patients may or may not have had a surgical resection.
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Patients must be expected to live the length of study
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Patients must be able to provide informed consent according to institutional guidelines.
Exclusion Criteria:
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Prior ovarian resection, unilateral or bilateral oophorectomy, hysterectomy or radiation to pelvic region.
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Pregnancy or breast feeding.
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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.
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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.
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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).
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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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Center for Reproductive Health | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- University of California, San Francisco
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Mitchell Rosen, MD, UCSF Center for Reproductive Health and Fertility Preservation
- Study Director: Michael Prados, MD, UCSF Department of Neurological Surgery and Helen Diller Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UCSF 10-03288
Study Results
Participant Flow
| Recruitment Details | Low recruitment necessitated the closing of the study. No results available. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cancer |
|---|---|
| Arm/Group Description | 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). |
| Period Title: Overall Study | |
| STARTED | 2 |
| COMPLETED | 2 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Cancer |
|---|---|
| Arm/Group Description | 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). |
| Overall Participants | 2 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
2
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
100%
|
| Male |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
2
100%
|
Outcome Measures
| Title | Ovarian Aging (AFC and Hormones) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data collection was terminated and analyses were not performed due to low enrollment |
| Arm/Group Title | Cancer |
|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | This is a non-treatment study so there was no reporting of AEs. Adverse events due to temozolomide treatment, if any, were handled as per institutional guidelines and the Cancer Center protocols. | |
| Arm/Group Title | Cancer | |
| Arm/Group Description | 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). Low recruitment necessitated the closing of the study. No results available. | |
All Cause Mortality |
||
| Cancer | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Cancer | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Cancer | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Mitchell Rosen |
|---|---|
| Organization | UCSF |
| Phone | 415-353-7394 |
| thomas.remble@ucsfmedctr.org |
- UCSF 10-03288