ALTE2131

Summary

This phase III trial compares the effect of giving triptorelin versus 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.

Study plan: This study aims to measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy, collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment, and measure estrogen deprivation symptoms, menstrual pattern, and quality of life among patients receiving triptorelin.

• 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.

To be included in this study, participants must be / have 

• All patients must be younger than 40 at the time of enrollment
• Patient must be a post-menarchal female and report that their initial menstrual period occurred more than 6 months prior to enrollment
• 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

To be included in this study, participants must not be / have

• Any planned radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
• Planned bilateral oophorectomy.
• 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
• Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment.
• Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.

Keywords

Chemotherapy; Ovaries