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NCT06513962PHASE3Recruiting

Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

Children's Oncology Group

Start Date

2/27/2025

Completion Date

10/30/2029

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 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

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.

Eligibility Criteria

Age Range: No minimum to 39 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. * 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).

Interventions

OTHER

Best Practice

PROCEDURE

Biospecimen Collection

OTHER

Electronic Health Record Review

OTHER

Survey Administration

DRUG

Triptorelin Pamoate

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Conditions

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Locations

Children's Hospital of Alabama

Birmingham, Alabama 35233

United States

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama 35233

United States

USA Health Strada Patient Care Center

Mobile, Alabama 36604

United States

Phoenix Childrens Hospital

Phoenix, Arizona 85016

United States

Banner University Medical Center - Tucson

Tucson, Arizona 85719

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas 72903

United States

Arkansas Children's Hospital

Little Rock, Arkansas 72202-3591

United States

CARTI Cancer Center

Little Rock, Arkansas 72205

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Loma Linda University Medical Center

Loma Linda, California 92354

United States

Mattel Children's Hospital UCLA

Los Angeles, California 90095

United States

Kaiser Permanente-Oakland

Oakland, California 94611

United States

Children's Hospital of Orange County

Orange, California 92868

United States

Sutter Medical Center Sacramento

Sacramento, California 95816

United States

UC San Diego Medical Center - Hillcrest

San Diego, California 92103

United States

Rady Children's Hospital - San Diego

San Diego, California 92123

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado 80218

United States

Connecticut Children's Medical Center

Hartford, Connecticut 06106

United States

Beebe Medical Center

Lewes, Delaware 19958

United States

Beebe South Coastal Health Campus

Millville, Delaware 19967

United States

Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware 19718

United States

Beebe Health Campus

Rehoboth Beach, Delaware 19971

United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware 19801

United States

Alfred I duPont Hospital for Children

Wilmington, Delaware 19803

United States

Children's National Medical Center

Washington D.C., District of Columbia 20010

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida 33908

United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida 32610

United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida 33021

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida 32207

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida 33136

United States

Nicklaus Children's Hospital

Miami, Florida 33155

United States

Miami Cancer Institute

Miami, Florida 33176

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Nemours Children's Hospital

Orlando, Florida 32827

United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida 32504

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida 33607

United States

Saint Mary's Medical Center

West Palm Beach, Florida 33407

United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia 30329

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii 96826

United States

OSF Saint Anthony's Health Center

Alton, Illinois 62002

United States

Rush-Copley Medical Center

Aurora, Illinois 60504

United States

Saint Mary's Hospital

Centralia, Illinois 62801

United States

Lurie Children's Hospital-Chicago

Chicago, Illinois 60611

United States

Northwestern University

Chicago, Illinois 60611

United States

University of Illinois

Chicago, Illinois 60612

United States

Carle at The Riverfront

Danville, Illinois 61832

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois 60115

United States

Carle Physician Group-Effingham

Effingham, Illinois 62401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois 60134

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois 60030

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois 60045

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois 61938

United States

SSM Health Good Samaritan

Mount Vernon, Illinois 62864

United States

Carle BroMenn Medical Center

Normal, Illinois 61761

United States

Carle Cancer Institute Normal

Normal, Illinois 61761

United States

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois 60453

United States

Northwestern Medicine Orland Park

Orland Park, Illinois 60462

United States

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois 60068

United States

Memorial Hospital East

Shiloh, Illinois 62269

United States

Saint John's Hospital

Springfield, Illinois 62702

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Carle Cancer Center

Urbana, Illinois 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois 60555

United States

Rush-Copley Healthcare Center

Yorkville, Illinois 60560

United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

Riley Hospital for Children

Indianapolis, Indiana 46202

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa 50023

United States

Saint Anthony Regional Hospital

Carroll, Iowa 51401

United States

Mercy Cancer Center-West Lakes

Clive, Iowa 50325

United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa 50325

United States

Greater Regional Medical Center

Creston, Iowa 50801

United States

Blank Children's Hospital

Des Moines, Iowa 50309

United States

Iowa Methodist Medical Center

Des Moines, Iowa 50309

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa 50309

United States

Broadlawns Medical Center

Des Moines, Iowa 50314

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa 50314

United States

UI Healthcare Mission Cancer and Blood - Fort Dodge

Fort Dodge, Iowa 50501

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa 52242

United States

UI Healthcare Mission Cancer and Blood - Pella

Pella, Iowa 50219

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa 50263

United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa 50266

United States

The Iowa Clinic PC

West Des Moines, Iowa 50266

United States

Central Care Cancer Center - Garden City

Garden City, Kansas 67846

United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas 67530

United States

Norton Children's Hospital

Louisville, Kentucky 40202

United States

Children's Hospital New Orleans

New Orleans, Louisiana 70118

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana 70121

United States

Maine Children's Cancer Program

Scarborough, Maine 04074

United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine 04074

United States

Walter Reed National Military Medical Center

Bethesda, Maryland 20889-5600

United States

Christiana Care - Union Hospital

Elkton, Maryland 21921

United States

C S Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan 48109

United States

Bronson Battle Creek

Battle Creek, Michigan 49017

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan 49503

United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan 49007

United States

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan 49009

United States

Beacon Kalamazoo

Kalamazoo, Michigan 49048

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan 49444

United States

Corewell Health Reed City Hospital

Reed City, Michigan 49677

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan 49085

United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan 49085

United States

Munson Medical Center

Traverse City, Michigan 49684

United States

University of Michigan Health - West

Wyoming, Michigan 49519

United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota 55404

United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota 55455

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri 63011

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri 65613

United States

Cox Cancer Center Branson

Branson, Missouri 65616

United States

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri 63703

United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri 63376

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri 63141

United States

Freeman Health System

Joplin, Missouri 64804

United States

Mercy Hospital Joplin

Joplin, Missouri 64804

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri 64108

United States

Lake Regional Hospital

Osage Beach, Missouri 65065

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri 65401

United States

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri 64506

United States

Mercy Hospital Springfield

Springfield, Missouri 65804

United States

CoxHealth South Hospital

Springfield, Missouri 65807

United States

Mercy Infusion Center - Chippewa

St Louis, Missouri 63109

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Mercy Hospital South

St Louis, Missouri 63128

United States

Siteman Cancer Center-South County

St Louis, Missouri 63129

United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri 63136

United States

Mercy Hospital Saint Louis

St Louis, Missouri 63141

United States

Mercy Hospital Washington

Washington, Missouri 63090

United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska 68114

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Presbyterian Hospital

Albuquerque, New Mexico 87106

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico 87106

United States

Albany Medical Center

Albany, New York 12208

United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York 10032

United States

NYP/Weill Cornell Medical Center

New York, New York 10065

United States

University of Rochester

Rochester, New York 14642

United States

Stony Brook University Medical Center

Stony Brook, New York 11794

United States

Montefiore Medical Center - Moses Campus

The Bronx, New York 10467

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina 27599

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota 58122

United States

Children's Hospital Medical Center of Akron

Akron, Ohio 44308

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Dayton Children's Hospital

Dayton, Ohio 45404

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma 73120

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania 19317

United States

Penn State Children's Hospital

Hershey, Pennsylvania 17033

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania 19134

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania 15224

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Prisma Health Richland Hospital

Columbia, South Carolina 29203

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota 57117-5134

United States

Saint Jude Children's Research Hospital

Memphis, Tennessee 38105

United States

The Children's Hospital at TriStar Centennial

Nashville, Tennessee 37203

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee 37232

United States

Medical City Dallas Hospital

Dallas, Texas 75230

United States

Parkland Memorial Hospital

Dallas, Texas 75235

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas 75390

United States

El Paso Children's Hospital

El Paso, Texas 79905

United States

Cook Children's Medical Center

Fort Worth, Texas 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas 77030

United States

UT MD Anderson Cancer Center

Houston, Texas 77030

United States

Children's Hospital of San Antonio

San Antonio, Texas 78207

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

Carilion Children's

Roanoke, Virginia 24014

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Washington Medical Center - Montlake

Seattle, Washington 98195

United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington 99204

United States

Madigan Army Medical Center

Tacoma, Washington 98431

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin 54303

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin 53792

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin 53226

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin 53233

United States

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin 54154

United States

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin 53081

United States

Sheboygan Physicians Group

Sheboygan, Wisconsin 53081

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin 54235-1495

United States

CancerCare Manitoba

Winnipeg, Manitoba R3E 0V9

Canada

The Montreal Children's Hospital of the MUHC

Montreal, Quebec H3H 1P3

Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec H3T 1C5

Canada

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Québec, G1V 4G2

Canada