Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients with Newly Diagnosed Lymphomas

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedBiomarker/Laboratory analysis, Supportive care21 and underALTE11C1
NCI-2013-00069, COG-ALTE11C1, NCT01793233

Trial Description

Summary

This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.

Further Study Information

PRIMARY OBJECTIVES:

I. Compare anti mullerian hormone (AMH), follicle stimulating hormone (FSH), and estradiol (E2) between patients at baseline and cross section of controls and again between patients at 12 months off therapy and cross section of controls.

II. Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.

III. Evaluate degree of change of AMH/FSH/E2 from baseline to end of therapy in patients.

IV. Evaluate degree of recovery of AMH/FSH/E2 from end of therapy to 12 months off therapy.

SECONDARY OBJECTIVES:

I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy.

II. Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.

OUTLINE:

Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collection at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.

Eligibility Criteria

Inclusion Criteria:

Planned cancer treatment must include an alkylating agent: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

All patients and/or their parents or legal guardians must sign a written informed consent

Patients may take hormone medications excluding gonadotropin-releasing hormone (GnRH) analogues

Patients with any performance status are eligible for enrollment

Patients must be newly diagnosed with lymphoma; this includes but is not limited to Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic large cell lymphoma

Patients must have had first menses >= 6 months prior to enrollment

Exclusion Criteria:

Patients who have undergone or are planning to undergo ovarian tissue, oocyte or embryo cryopreservation prior to treatment are not eligible

Patients who are pregnant or breast feeding are not eligible

Patients who have received gonadotropin release hormone agonist or antagonist (e.g. Lupron) prior to study entry are not eligible

Patients who previously have had their uterus or ovary(ies) removed are not eligible

Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic irradiation, cranial irradiation or hematopoietic stem cell transplantation are not eligible

Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic ovarian syndrome are not eligible

Patients who have a secondary malignancy are not eligible

Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Children's Oncology Group

  • National Cancer Institute
Jennifer M. Levine, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama

Alyssa Terry Reddy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Alyssa Terry Reddy
Principal Investigator

California
Duarte

City of Hope Comprehensive Cancer Center

Anna Beata Pawlowska
Ph: 800-826-4673
Email: becomingapatient@coh.org

Anna Beata Pawlowska
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Albert Kheradpour
Ph: 909-558-3375

Albert Kheradpour
Principal Investigator

Long Beach

Miller Children's and Women's Hospital Long Beach

Cecilia Hsing-I Fu
Ph: 323-361-4110

Cecilia Hsing-I Fu
Principal Investigator

Orange

Children's Hospital of Orange County

Violet Shen
Ph: 714-997-3000

Violet Shen
Principal Investigator

Palo Alto

Lucile Packard Children's Hospital Stanford University

Neyssa Maria Marina
Ph: 650-498-7061
Email: clinicaltrials@med.stanford.edu

Neyssa Maria Marina
Principal Investigator

San Diego

Rady Children's Hospital - San Diego

William D. Roberts
Ph: 858-966-5934

William D. Roberts
Principal Investigator

San Francisco

UCSF Medical Center-Mission Bay

Robert Edward Goldsby
Ph: 877-827-3222

Robert Edward Goldsby
Principal Investigator

Connecticut
Hartford

Connecticut Children's Medical Center

Michael Scott Isakoff
Ph: 860-545-9981

Michael Scott Isakoff
Principal Investigator

Delaware
Wilmington

Alfred I duPont Hospital for Children

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

District of Columbia
Washington

Children's National Medical Center

Jeffrey Stuart Dome
Ph: 202-884-2549

Jeffrey Stuart Dome
Principal Investigator

Florida
Fort Myers

Golisano Children's Hospital of Southwest Florida

Emad K. Salman
Ph: 239-343-5333

Emad K. Salman
Principal Investigator

Jacksonville

Nemours Children's Clinic-Jacksonville

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Miami

Baptist Hospital of Miami

Doured Daghistani
Ph: 800-599-2456
Email: cancerinfo@baptisthealth.net

Doured Daghistani
Principal Investigator

Orlando

Nemours Children's Hospital

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Ramamoorthy Nagasubramanian
Principal Investigator

Saint Petersburg

All Children's Hospital

Gregory Alan Hale
Ph: 727-767-2423
Email: HamblinF@allkids.org

Gregory Alan Hale
Principal Investigator

Tampa

Tampa General Hospital

Cameron K. Tebbi
Ph: 800-882-4123
Email: hkourtellis@tgh.org

Cameron K. Tebbi
Principal Investigator

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

Frank G. Keller
Ph: 888-785-1112

Frank G. Keller
Principal Investigator

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W. Wilkinson
Ph: 808-983-6090

Robert W. Wilkinson
Principal Investigator

Idaho
Boise

Saint Luke's Mountain States Tumor Institute

Eugenia Chang
Ph: 800-845-4624

Eugenia Chang
Principal Investigator

Illinois
Chicago

Lurie Children's Hospital-Chicago

Yasmin Castellanes Gosiengfiao
Ph: 773-880-4562

Yasmin Castellanes Gosiengfiao
Principal Investigator

University of Chicago Comprehensive Cancer Center

Susan Lerner Cohn
Ph: 773-834-7424

Susan Lerner Cohn
Principal Investigator

Indiana
Indianapolis

Riley Hospital for Children

Robert J. Fallon
Ph: 888-823-5923
Email: ctsucontact@westat.com

Robert J. Fallon
Principal Investigator

Iowa
Des Moines

Blank Children's Hospital

Wendy Leigh Woods-Swafford
Ph: 515-241-6729

Wendy Leigh Woods-Swafford
Principal Investigator

Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Ayman Ali El-Sheikh
Ph: 800-237-1225

Ayman Ali El-Sheikh
Principal Investigator

Kentucky
Lexington

University of Kentucky/Markey Cancer Center

Lars Martin Wagner
Ph: 859-257-3379

Lars Martin Wagner
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Kenneth J. Cohen
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Kenneth J. Cohen
Principal Investigator

Sinai Hospital of Baltimore

Joseph M. Wiley
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Joseph M. Wiley
Principal Investigator

Michigan
Detroit

Wayne State University/Karmanos Cancer Institute

Meret Henry
Ph: 313-576-9363

Meret Henry
Principal Investigator

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David Scott Dickens
Ph: 616-267-1925

David Scott Dickens
Principal Investigator

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Michael Kerr Richards
Ph: 612-813-5193

Michael Kerr Richards
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Gail Cranshaw Megason
Ph: 601-815-6700

Gail Cranshaw Megason
Principal Investigator

Missouri
Columbia

Columbia Regional

Thomas W. Loew
Ph: 573-882-7440

Thomas W. Loew
Principal Investigator

Kansas City

The Childrens Mercy Hospital

Maxine Lorraine Hetherington
Ph: 816-234-3265

Maxine Lorraine Hetherington
Principal Investigator

Nevada
Las Vegas

Children's Specialty Center of Nevada II

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Nevada Cancer Research Foundation CCOP

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Sunrise Hospital and Medical Center

Nik Farahana Nik Abdul Rashid
Ph: 702-384-0013

Nik Farahana Nik Abdul Rashid
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical Center

Michael Bertram Harris
Ph: 201-996-2879

Michael Bertram Harris
Principal Investigator

Morristown

Morristown Medical Center

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

Newark

Newark Beth Israel Medical Center

Stacey Rifkin-Zenenberg
Ph: 973-322-2470

Stacey Rifkin-Zenenberg
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Koh B. Boayue
Ph: 505-272-6972

Koh B. Boayue
Principal Investigator

New York
Albany

Albany Medical Center

Vikramjit Singh Kanwar
Ph: 518-262-3368

Vikramjit Singh Kanwar
Principal Investigator

Bronx

Montefiore Medical Center - Moses Campus

Peter David Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Peter David Cole
Principal Investigator

Buffalo

Roswell Park Cancer Institute

Denise A. Rokitka
Ph: 877-275-7724

Denise A. Rokitka
Principal Investigator

Mineola

Winthrop University Hospital

Mark E. Weinblatt
Ph: 866-946-8476

Mark E. Weinblatt
Principal Investigator

New York

Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Alice Lee
Principal Investigator

Stony Brook

Stony Brook University Medical Center

Robert Ingalls Parker
Ph: 800-862-2215

Robert Ingalls Parker
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Karol Hicks Kerr
Ph: 315-464-5476

Karol Hicks Kerr
Principal Investigator

Valhalla

New York Medical College

Jessica Cassara Hochberg
Ph: 914-594-3794

Jessica Cassara Hochberg
Principal Investigator

North Carolina
Asheville

Mission Hospital-Memorial Campus

Douglas James Scothorn
Ph: 828-213-4150

Douglas James Scothorn
Principal Investigator

Greenville

East Carolina University

George Edward Hucks
Ph: 252-744-2391

George Edward Hucks
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Thomas Bennett Russell
Ph: 336-713-6771

Thomas Bennett Russell
Principal Investigator

North Dakota
Fargo

Sanford Medical Center-Fargo

Samuel Odame Anim
Ph: 701-234-6161

Samuel Odame Anim
Principal Investigator

Ohio
Cleveland

Rainbow Babies and Childrens Hospital

Yousif (Joe) H. Matloub
Ph: 216-844-5437

Yousif (Joe) H. Matloub
Principal Investigator

Columbus

Nationwide Children's Hospital

Mark Anthony Ranalli
Ph: 614-722-2708

Mark Anthony Ranalli
Principal Investigator

Toledo

The Toledo Hospital/Toledo Children's Hospital

Jamie L. Dargart
Ph: 419-824-1842

Jamie L. Dargart
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Rene Yvonne McNall-Knapp
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Rene Yvonne McNall-Knapp
Principal Investigator

Oregon
Portland

Oregon Health and Science University

Susan Joy Lindemulder
Ph: 503-494-1080
Email: trials@ohsu.edu

Susan Joy Lindemulder
Principal Investigator

Pennsylvania
Philadelphia

Children's Hospital of Philadelphia

Jill P. Ginsberg
Ph: 215-590-2810

Jill P. Ginsberg
Principal Investigator

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Peter H. Shaw
Ph: 412-692-5573

Peter H. Shaw
Principal Investigator

Tennessee
Knoxville

East Tennessee Childrens Hospital

Ray C. Pais
Ph: 865-541-8266

Ray C. Pais
Principal Investigator

Memphis

St. Jude Children's Research Hospital

Wayne Lee Furman
Ph: 866-278-5833
Email: info@stjude.org

Wayne Lee Furman
Principal Investigator

Nashville

Vanderbilt University/Ingram Cancer Center

Debra L. Friedman
Ph: 800-811-8480

Debra L. Friedman
Principal Investigator

Texas
Dallas

UT Southwestern/Simmons Cancer Center-Dallas

Martha Marie Stegner
Ph: 214-648-7097

Martha Marie Stegner
Principal Investigator

Fort Worth

Cook Children's Medical Center

Karen Halaburt Albritton
Ph: 682-885-2103

Karen Halaburt Albritton
Principal Investigator

San Antonio

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

Jaime Estrada
Principal Investigator

University of Texas Health Science Center at San Antonio

Anne-Marie R. Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Anne-Marie R. Langevin
Principal Investigator

Virginia
Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7243

Eric Jeffrey Lowe
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Gita Vasers Massey
Ph: 804-628-1939

Gita Vasers Massey
Principal Investigator

Washington
Seattle

Seattle Children's Hospital

Douglas S. Hawkins
Ph: 866-987-2000

Douglas S. Hawkins
Principal Investigator

Spokane

Providence Sacred Heart Medical Center and Children's Hospital

Judy L. Felgenhauer
Ph: 800-228-6618
Email: HopeBeginsHere@providence.org

Judy L. Felgenhauer
Principal Investigator

Wisconsin
Madison

University of Wisconsin Hospital and Clinics

Kenneth Brian DeSantes
Ph: 608-262-5223

Kenneth Brian DeSantes
Principal Investigator

Milwaukee

Midwest Children's Cancer Center

Paul David Harker-Murray
Ph: 414-805-4380

Paul David Harker-Murray
Principal Investigator

Canada

Manitoba
Winnipeg

CancerCare Manitoba

Rochelle Avis Yanofsky
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Rochelle Avis Yanofsky
Principal Investigator

Nova Scotia
Halifax

IWK Health Centre

Conrad Vincent Fernandez
Ph: 902-470-8394

Conrad Vincent Fernandez
Principal Investigator

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana Pradier Silva
Ph: 613-544-2630

Mariana Pradier Silva
Principal Investigator

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline Mary Lewis Halton
Ph: 613-738-3931

Jacqueline Mary Lewis Halton
Principal Investigator

Quebec
Montreal

Centre Hospitalier Universitaire Sainte-Justine

Yvan Samson
Ph: 514-345-4931

Yvan Samson
Principal Investigator

The Montreal Children's Hospital of the MUHC

Sharon Barbara Abish
Ph: 514-412-4445
Email: info@thechildren.com

Sharon Barbara Abish
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01793233

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.