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



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:5 - 50
Updated:2/24/2019
Start Date:June 5, 2017
End Date:October 1, 2020

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LEAHRN (Late Effects After High-Risk Neuroblastoma) Study

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.

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.

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
We found this trial at
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Mark A. Ranalli
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
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Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Denise A. Rokitka
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Rajaram Nagarajan
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Stanton C. Goldman
Phone: 972-566-5588
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
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Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Anderson (Andy) B. Collier
Phone: 601-815-6700
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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262 Danny Thomas Pl
Memphis, Tennessee 38105
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747 52nd St
Oakland, California 94609
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
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South 34th Street
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
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7700 Floyd Curl Dr
San Antonio, Texas 78229
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4502 Medical Drive
San Antonio, Texas 78284
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1600 Rockland Road
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(302) 651-4200
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2401 W Belvedere Ave
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450 Brookline Ave
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171 Ashley Avenue
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5841 S Maryland Ave
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Chicago, Illinois 60614
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Dallas, Texas 75390
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9333 Imperial Highway
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2301 Erwin Rd
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919-684-8111
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801 7th Avenue
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1600 Southwest Archer Road
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900 West Faris Rd.
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30 Prospect Ave
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Jacksonville, Florida 32207
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2018 W Clinch Ave
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Lexington, Kentucky
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1 Children's Way
Little Rock, Arkansas 72202
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600 Highland Ave
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Minneapolis, Minnesota 55455
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2525 Chicago Ave
Minneapolis, Minnesota 55404
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Nashville, Tennessee 37232
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New Haven, Connecticut 6520
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940 NE 13th St
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13535 Nemours Parkway
Orlando, Florida 32827
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725 Welch Rd
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Perth, Western Australia
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1919 E Thomas Rd
Phoenix, Arizona 85006
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660 S Euclid Ave
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4800 Sand Point Way NE
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1305 W 18th St
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1 Medical Center Blvd
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