Electronic Health Record Review: Ancillary studies
Survey Administration: Ancillary studies
Triptorelin Pamoate: Given IM
Study summary
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 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.
Eligibility
Sex
FEMALE
Min age
—
Max age
39 Years
Healthy volunteers
No
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.
* Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
* 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):
* For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
* For patients ≥ 20 years of age and \< 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
* For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.
Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.
* The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
* 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.
* Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days 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).
Primary outcome measure(s)
Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years — Up to 2 years post-chemotherapy Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time.
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years — Up to 2 years post-chemotherapy Accrual rates of newly diagnosed AYA female cancer patients age \< 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period.
Anti-mullerian hormone (AMH) levels — At 2 years post-chemotherapy Feasibility of measuring AMH at two years post completion of alkylating agent-containing chemotherapy among randomized patients.
Trial sites (206)
Facility
City
Region
Status
Children's Hospital of Alabama
Birmingham
Alabama
Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Recruiting
USA Health Strada Patient Care Center
Mobile
Alabama
Recruiting
Phoenix Childrens Hospital
Phoenix
Arizona
Recruiting
Banner University Medical Center - Tucson
Tucson
Arizona
Recruiting
Mercy Hospital Fort Smith
Fort Smith
Arkansas
Recruiting
Arkansas Children's Hospital
Little Rock
Arkansas
Recruiting
CARTI Cancer Center
Little Rock
Arkansas
Recruiting
City of Hope Comprehensive Cancer Center
Duarte
California
Recruiting
UC San Diego Moores Cancer Center
La Jolla
California
Recruiting
Loma Linda University Medical Center
Loma Linda
California
Recruiting
Mattel Children's Hospital UCLA
Los Angeles
California
Recruiting
Kaiser Permanente-Oakland
Oakland
California
Recruiting
Children's Hospital of Orange County
Orange
California
Recruiting
Sutter Medical Center Sacramento
Sacramento
California
Recruiting
UC San Diego Medical Center - Hillcrest
San Diego
California
Suspended
Rady Children's Hospital - San Diego
San Diego
California
Recruiting
Children's Hospital Colorado
Aurora
Colorado
Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver
Colorado
Recruiting
Connecticut Children's Medical Center
Hartford
Connecticut
Recruiting
Beebe Medical Center
Lewes
Delaware
Recruiting
Beebe South Coastal Health Campus
Millville
Delaware
Recruiting
Helen F Graham Cancer Center
Newark
Delaware
Recruiting
Medical Oncology Hematology Consultants PA
Newark
Delaware
Recruiting
Christiana Care Health System-Christiana Hospital
Newark
Delaware
Recruiting
Beebe Health Campus
Rehoboth Beach
Delaware
Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington
Delaware
Recruiting
Alfred I duPont Hospital for Children
Wilmington
Delaware
Recruiting
Children's National Medical Center
Washington D.C.
District of Columbia
Recruiting
Golisano Children's Hospital of Southwest Florida
Fort Myers
Florida
Recruiting
UF Health Cancer Institute - Gainesville
Gainesville
Florida
Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Florida
Recruiting
Nemours Children's Clinic-Jacksonville
Jacksonville
Florida
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida
Recruiting
Nicklaus Children's Hospital
Miami
Florida
Recruiting
Miami Cancer Institute
Miami
Florida
Recruiting
AdventHealth Orlando
Orlando
Florida
Recruiting
Nemours Children's Hospital
Orlando
Florida
Recruiting
Nemours Children's Clinic - Pensacola
Pensacola
Florida
Recruiting
Tampa General Hospital
Tampa
Florida
Recruiting
+ 166 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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