Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
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.
PRIMARY OBJECTIVES:
I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age < 40 years (exclusive of breast cancer).
II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients.
SECONDARY OBJECTIVES:
I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients.
II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients.
EXPLORATORY OBJECTIVE:
I. Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to or within 7 days after the start of 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.
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, or dacarbazine (DTIC).
Expected cumulative cyclophosphamide equivalent dose (CED):
Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.
Exclusion Criteria:
Birmingham, Alabama 35233, United States
oncologyresearch@peds.uab.edu205-638-9285
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Hollywood, Florida 33021, United States
Miami, Florida 33136, United States
Tampa, Florida 33607, United States
Atlanta, Georgia 30329, United States
Indianapolis, Indiana 46202, United States
Clive, Iowa 50325, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Grand Rapids, Michigan 49503, United States
Grand Rapids, Michigan 49503, United States
Norton Shores, Michigan 49444, United States
Saint Joseph, Michigan 49085, United States
Saint Joseph, Michigan 49085, United States
Minneapolis, Minnesota 55404, United States
City of Saint Peters, Missouri 63376, United States
New York, New York 10032, United States
Chapel Hill, North Carolina 27599, United States
Chadds Ford, Pennsylvania 19317, United States
Sioux Falls, South Dakota 57117-5134, United States
Houston, Texas 77030, United States
Seattle, Washington 98195, United States
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Green Bay, Wisconsin 54303, United States
Madison, Wisconsin 53718, United States
Madison, Wisconsin 53792, United States
Oconto Falls, Wisconsin 54154, United States
Sheboygan, Wisconsin 53081, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Sherbrooke, Quebec J1H 5N4, Canada
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