Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer
Investigational Medication for Protecting Egg-Producing Organs in Young Cancer Patients
Amanda J. Saraf, DO
Primary Investigator
Brief description of study
What is the purpose of this study?
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.
Detailed description of study
What will happen during the study?
Patients are randomized to 1 of 2 arms.
ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 1 and 2 years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hematopoietic and Lymphatic System, Neoplasm Malignant Solid Neoplasm, Riley
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Age: 40 years or below
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Gender: Female
Inclusion Criteria:
- < 40 years of age at the time of enrollment
- Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
- Newly diagnosed with first cancer, exclusive of breast cancer.
- Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard.
- For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
- Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
- Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
- Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
- Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
- Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
- Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment.
- Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
- Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).
This study investigates the effects of an investigational medication on protecting the ovaries in young females with cancer who are receiving chemotherapy. Chemotherapy, particularly with alkylating agents, can harm the ovaries, making it hard to get pregnant later. The investigational medication may help by slowing down the ovaries during chemotherapy, potentially reducing damage.
Participants in the study will be assigned to one of two study arms. In Arm A, participants receive the investigational medication before starting chemotherapy and may receive a second dose if needed. In Arm B, participants receive standard chemotherapy without the investigational medication. Blood samples will be collected throughout the study to monitor the effects.
- Who can participate: Females under 40 years old who have menstruated for at least 6 months and are newly diagnosed with their first cancer are eligible. They must plan to receive certain chemotherapy agents and not have had previous pelvic radiation or specific medical conditions.
- Study details: Participants will be randomly assigned to receive either triptorelin or standard chemotherapy. Blood samples will be taken throughout the study to monitor effects.
