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Clinical Trial Finder

Search Results

Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma

Study Purpose

This research trial studies late effects after treatment in patients with previously diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide which treatments for high-risk neuroblastoma are better tolerated with less side effects over time.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 5 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have been enrolled on COG neuroblastoma biology study ANBL00B1.
  • - Patient must have been diagnosed with high-risk neuroblastoma per ANBL00B1 definition.
  • - Patient must have been diagnosed on or after January 1, 2000.
  • - At least 5 years must have elapsed since diagnosis.
  • - Patients must have been treated for high-risk neuroblastoma.
  • - Note: patients may have had any therapy for high-risk neuroblastoma, including second line or non-established therapies (for example in the setting of less than optimal initial response or concerns for high risk of relapse); patients may have received therapy for refractory or relapsed neuroblastoma, or treatment for an SMN; however all cytotoxic anti-neuroblastoma therapy should have been administered >= 2 years of the enrollment date; SMN therapy may be completed or ongoing at the time of enrollment.

Exclusion Criteria:

  • - Patients must not be currently receiving active anti-neuroblastoma cytotoxic chemotherapy.
  • - Patients must not have received anti-neuroblastoma cytotoxic chemotherapy within the last two years.
  • - Note: cytotoxic therapies include (but are not limited to) chemotherapy (platinum agents, alkylators, anthracyclines, topoisomerases, vinca alkaloids, other cytotoxic chemotherapy), any kind of transplant, MIBG therapy, and/or radiation therapy.
  • - Non-cytotoxic (biologic/targeted/differentiating/other) therapies are permitted at the time of enrollment; for example, patients receiving oral differentiating agents, antiangiogenic therapy, immune modulators, holistic therapies, difluoromethylornithine (DMFO), other minimal residual disease (MRD) therapies/relapse-prevention therapies are eligible.
- Patients with current active neuroblastoma relapse are ineligible

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03057626
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tara O Henderson
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Active, not recruiting
Countries Australia, Canada, New Zealand, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Neuroblastoma, Stage 2A Neuroblastoma, Stage 2B Neuroblastoma, Stage 3 Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
Additional Details

PRIMARY OBJECTIVES:

  • I. To estimate the prevalence of organ dysfunction, subsequent malignant neoplasm (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction in a large cohort of representative 5-year survivors of high-risk neuroblastoma treated with modern therapy.
  • II. To identify the demographic, clinical and treatment-related risk factors associated with increased risk of organ dysfunction, SMN, growth impairment, abnormal pubertal development and neurobehavioral dysfunction in long-term survivors of high-risk neuroblastoma.
  • III. To explore the impact of new biologic therapies and diagnostics including immunotherapy, immunocytokines, isotretinoin (cis-retinoic acid) and iobenguane I-131 (131 I-MIBG) on the risk of late effects.
  • IV. To determine the impact of impaired organ function, physical growth, pubertal development, and neurobehavioral function on health-related quality of life (HRQOL) in long-term survivors of high-risk neuroblastoma.
SECONDARY OBJECTIVES:
  • I. To establish a cohort of high-risk neuroblastoma survivors, with stored peripheral blood samples, who were treated with multi-modal therapies since the year 2000 as a resource for future investigation.
OUTLINE: Patients undergo collection of blood and urine samples on day 1. Patients also undergo clinical assessments, laboratory, radiographic, and other ancillary studies on day 1.

Arms & Interventions

Arms

: Observational (specimen collection)

Patients undergo collection of blood and urine samples on day 1. Patients also undergo clinical assessments, laboratory, radiographic, and other ancillary studies on day 1.

Interventions

Other: - Cytology Specimen Collection Procedure

Undergo collection of blood and urine

Other: - Laboratory Biomarker Analysis

Correlative studies

Other: - Quality-of-Life Assessment

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital of Alabama, Birmingham, Alabama

Status

Address

Children's Hospital of Alabama

Birmingham, Alabama, 35233

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

Kaiser Permanente Downey Medical Center, Downey, California

Status

Address

Kaiser Permanente Downey Medical Center

Downey, California, 90242

City of Hope Comprehensive Cancer Center, Duarte, California

Status

Address

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Children's Hospital Los Angeles, Los Angeles, California

Status

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

UCSF Benioff Children's Hospital Oakland, Oakland, California

Status

Address

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

Kaiser Permanente-Oakland, Oakland, California

Status

Address

Kaiser Permanente-Oakland

Oakland, California, 94611

Palo Alto, California

Status

Address

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

UCSF Medical Center-Mission Bay, San Francisco, California

Status

Address

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

Children's Hospital Colorado, Aurora, Colorado

Status

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Yale University, New Haven, Connecticut

Status

Address

Yale University

New Haven, Connecticut, 06520

Alfred I duPont Hospital for Children, Wilmington, Delaware

Status

Address

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Broward Health Medical Center, Fort Lauderdale, Florida

Status

Address

Broward Health Medical Center

Fort Lauderdale, Florida, 33316

Fort Myers, Florida

Status

Address

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

Gainesville, Florida

Status

Address

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida

Status

Address

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

AdventHealth Orlando, Orlando, Florida

Status

Address

AdventHealth Orlando

Orlando, Florida, 32803

Arnold Palmer Hospital for Children, Orlando, Florida

Status

Address

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Nemours Children's Hospital, Orlando, Florida

Status

Address

Nemours Children's Hospital

Orlando, Florida, 32827

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida

Status

Address

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

Tampa, Florida

Status

Address

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

Tampa, Florida, 33607

Atlanta, Georgia

Status

Address

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322

Honolulu, Hawaii

Status

Address

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

Lurie Children's Hospital-Chicago, Chicago, Illinois

Status

Address

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

University of Illinois, Chicago, Illinois

Status

Address

University of Illinois

Chicago, Illinois, 60612

Chicago, Illinois

Status

Address

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois

Status

Address

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453

Advocate Children's Hospital-Park Ridge, Park Ridge, Illinois

Status

Address

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068

Saint Jude Midwest Affiliate, Peoria, Illinois

Status

Address

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

Blank Children's Hospital, Des Moines, Iowa

Status

Address

Blank Children's Hospital

Des Moines, Iowa, 50309

Iowa City, Iowa

Status

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

Lexington, Kentucky

Status

Address

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Norton Children's Hospital, Louisville, Kentucky

Status

Address

Norton Children's Hospital

Louisville, Kentucky, 40202

Children's Hospital New Orleans, New Orleans, Louisiana

Status

Address

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

Sinai Hospital of Baltimore, Baltimore, Maryland

Status

Address

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Baystate Medical Center, Springfield, Massachusetts

Status

Address

Baystate Medical Center

Springfield, Massachusetts, 01199

C S Mott Children's Hospital, Ann Arbor, Michigan

Status

Address

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Minneapolis, Minnesota

Status

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Minneapolis, Minnesota

Status

Address

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

University of Mississippi Medical Center, Jackson, Mississippi

Status

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Children's Mercy Hospitals and Clinics, Kansas City, Missouri

Status

Address

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Saint Louis, Missouri

Status

Address

Cardinal Glennon Children's Medical Center

Saint Louis, Missouri, 63104

Washington University School of Medicine, Saint Louis, Missouri

Status

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Hackensack University Medical Center, Hackensack, New Jersey

Status

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Saint Joseph's Regional Medical Center, Paterson, New Jersey

Status

Address

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Stony Brook University Medical Center, Stony Brook, New York

Status

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

Chapel Hill, North Carolina

Status

Address

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Charlotte, North Carolina

Status

Address

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Akron, Ohio

Status

Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Rainbow Babies and Childrens Hospital, Cleveland, Ohio

Status

Address

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

Nationwide Children's Hospital, Columbus, Ohio

Status

Address

Nationwide Children's Hospital

Columbus, Ohio, 43205

Oklahoma City, Oklahoma

Status

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Legacy Emanuel Children's Hospital, Portland, Oregon

Status

Address

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

Oregon Health and Science University, Portland, Oregon

Status

Address

Oregon Health and Science University

Portland, Oregon, 97239

Penn State Children's Hospital, Hershey, Pennsylvania

Status

Address

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

BI-LO Charities Children's Cancer Center, Greenville, South Carolina

Status

Address

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota

Status

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

East Tennessee Childrens Hospital, Knoxville, Tennessee

Status

Address

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

Saint Jude Children's Research Hospital, Memphis, Tennessee

Status

Address

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

Nashville, Tennessee

Status

Address

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Austin, Texas

Status

Address

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

Medical City Dallas Hospital, Dallas, Texas

Status

Address

Medical City Dallas Hospital

Dallas, Texas, 75230

Dallas, Texas

Status

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

Cook Children's Medical Center, Fort Worth, Texas

Status

Address

Cook Children's Medical Center

Fort Worth, Texas, 76104

Houston, Texas

Status

Address

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

San Antonio, Texas

Status

Address

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Naval Medical Center - Portsmouth, Portsmouth, Virginia

Status

Address

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197

Richmond, Virginia

Status

Address

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

Seattle Children's Hospital, Seattle, Washington

Status

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Spokane, Washington

Status

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Madison, Wisconsin

Status

Address

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

International Sites

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Status

Address

Princess Margaret Hospital for Children

Perth, Western Australia, 6008

Perth Children's Hospital, Perth, Western Australia, Australia

Status

Address

Perth Children's Hospital

Perth, Western Australia, 6009

Alberta Children's Hospital, Calgary, Alberta, Canada

Status

Address

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Status

Address

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9

IWK Health Centre, Halifax, Nova Scotia, Canada

Status

Address

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8

Hamilton, Ontario, Canada

Status

Address

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Status

Address

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Status

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Montreal, Quebec, Canada

Status

Address

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3

Montreal, Quebec, Canada

Status

Address

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5

Quebec, Canada

Status

Address

Centre Hospitalier Universitaire de Quebec

Quebec, , G1V 4G2

Starship Children's Hospital, Grafton, Auckland, New Zealand

Status

Address

Starship Children's Hospital

Grafton, Auckland, 1145

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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