Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/24/2019
Start Date:July 28, 2014

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Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma

This phase III trial studies how well response and biology-based risk factor-guided therapy
works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may
not need treatment until it progresses. In this case, observation may be sufficient.
Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and
what the best treatment is. Response and biology-based risk factor-guided therapy may be
effective in treating patients with non-high risk neuroblastoma and may help to avoid some of
the risks and side effects related to standard treatment.

PRIMARY OBJECTIVES:

I. To eliminate therapy as the initial approach for infants < 12 months of age with small
International Neuroblastoma Risk Group (INRG) stage L1 neuroblastoma while maintaining an
overall survival (OS) of 99%.

II. To eliminate therapy as the initial approach for non-high-risk patients < 18 months of
age with localized neuroblastoma and favorable biology (histologic and genomic features)
while maintaining an OS of 99%.

III. To achieve a 3-year OS of > 81% for infants < 18 months of age with INRG stage Ms
neuroblastoma using objective criteria for early initiation of a response-based treatment
algorithm.

SECONDARY OBJECTIVES:

I. To describe the time to intervention or tumor progression, type of intervention and site
of progression for patients with localized neuroblastoma who experience progression after an
initial period of observation.

II. To characterize the pharmacokinetic profile of the chemotherapeutic agents carboplatin
and etoposide in patients with stage Ms disease.

III. To define the genomic profile of tumors from patients with non-high-risk neuroblastoma
both at initial biopsy and at the time of subsequent biopsy or surgical resection.

IV. To describe the histology of tumor specimens obtained at the time of subsequent biopsy or
surgical resection.

V. To determine the salvage rate (OS) of patients with tumor relapse or disease progression.

VI. To determine the procedural complication rate (initial biopsy, resection [intraoperative
and postoperative], subsequent biopsy) and correlate with the degree of surgical resection.

VII. To determine the rate of reduction in image defined risk factors (IDRF) in L2 tumors
following observation or chemotherapy.

OUTLINE: Patients are assigned to 1 of 3 treatment groups.

GROUP A: Patients undergo clinical observation for 96 weeks in the absence disease
progression.

GROUP B: Patients undergo clinical observation for 3 years in the absence of disease
progression. Upon disease progression, patients undergo surgery or receive first-line
chemotherapy comprising carboplatin intravenously (IV) over 1 hour on day 1 (courses 1, 2, 4,
6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide
IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15
minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days
for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a
partial response (PR) or better is achieved, patients undergo clinical observation for 3
years.

GROUP C: Patients at high risk for deterioration and a poor outcome immediately receive
first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3
years in the absence of disease progression. Upon disease progression, patients receive
first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo
clinical observation for 3 years.

After completion of study treatment, patients are followed up annually for 3 years.

Inclusion Criteria:

- Patients must be:

- < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or

- < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms
neuroblastoma/ganglioneuroblastoma

- Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients

- Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene
neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International
Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN
non-amplified ganglioneuroblastoma verified by histology

- Patients must meet the specified criteria for one of the treatment groups defined
below; genomic features include MYCN gene amplification, segmental chromosome
aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number
gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index

- ?Favorable? genomic features are defined by one or more whole-chromosome gains or
hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome
aberrations as defined above

- ?Unfavorable? genomic features are defined by the presence of any segmental
chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic
copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this
includes copy neutral loss of heterozygosity (LOH)

- Only patients with MYCN non-amplified tumors are eligible for this study

- Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1
neuroblastoma/ganglioneuroblastoma who meet the following criteria:

- Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin

- Patients with non-adrenal primaries are eligible, but must have positive uptake
on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites
(urine or serum) to support the diagnosis of neuroblastoma

- No prior tumor resection or biopsy

- Group A will be further split into two subsets, which are mutually exclusive, for
statistical purposes

- Group A1:

- > 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in
greatest diameter OR

- Patients less than 6 months of age with an adrenal primary tumor > 3.1 and <
5 cm in greatest diameter OR

- < 12 months of age with a non-adrenal primary site < 5 cm in greatest
diameter

- Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in
greatest diameter.

- Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2
neuroblastoma/ganglioneuroblastoma who meet the following criteria:

- No life threatening symptoms or no impending neurologic or other organ function
compromise (e.g. epidural or intraspinal tumors with existing or impending
neurologic impairment, periorbital or calvarial-based lesions with existing or
impending cranial nerve impairment, anatomic or mechanical compromise of critical
organ function by tumor [abdominal compartment syndrome, urinary obstruction,
etc.]); horner syndrome is not considered neurologic compromise

- No prior tumor resection, tumor biopsy ONLY

- Only patients with both favorable histology and favorable genomic features will
remain on study as part of Group B; the institution will be notified of
histologic and genomic results within 3 weeks of specimen submission on ANBL00B1
or APEC14B1

- Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms
neuroblastoma/ganglioneuroblastoma

- No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is
allowed

- 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:

- Patients with MYCN amplified tumors are not eligible

- Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive
diagnostic procedure

- Group A and C patients, not required to undergo tumor biopsy, who do not enroll on
ANBL1232 within 4 weeks of confirmatory imaging study
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Principal Investigator: Barbara A. Gruner
Phone: 573-882-7440
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Principal Investigator: Stuart L. Cramer
Phone: 803-434-3680
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Dallas, Texas 75390
Principal Investigator: Tanya C. Watt
Phone: 214-648-7097
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Jagadeesh Ramdas
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Dayton, Ohio 45404
Principal Investigator: Ayman A. El-Sheikh
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Dayton, OH
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Denver, Colorado 80218
Principal Investigator: Jennifer J. Clark
Phone: 866-775-6246
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Denver, CO
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Roland L. Chu
Phone: 313-576-9790
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, Michigan 48236
Principal Investigator: Adonis N. Lorenzana
Phone: 734-712-3671
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Susan G. Kreissman
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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East Lansing, Michigan 48824
Principal Investigator: Renuka Gera
Phone: 517-975-9547
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East Lansing, MI
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El Paso, Texas 79905
Principal Investigator: Lisa L. Hartman
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El Paso, TX
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801 Broadway North
Fargo, North Dakota 58122
Principal Investigator: Samuel O. Anim
Phone: 800-437-4010
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Fargo, ND
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
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Fort Myers, FL
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Mary Meaghan P. Granger
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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1600 Southwest Archer Road
Gainesville, Florida 32610
Principal Investigator: William B. Slayton
Phone: 352-273-8010
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Gainesville, FL
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, MI
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Andrea R. Whitfield
Phone: 252-744-1015
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Nichole L. Bryant
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Katharine Offer
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hershey, Pennsylvania 17033
Principal Investigator: Lisa M. McGregor
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Hershey, PA
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Hollywood, Florida 33021
Principal Investigator: Iftikhar Hanif
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Hollywood, FL
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Principal Investigator: Wade T. Kyono
Phone: 808-983-6090
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Honolulu, HI
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1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
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Honolulu, HI
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Houston, Texas 77030
Principal Investigator: Jennifer H. Foster
Phone: 713-798-1354
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Hunter Regional Mail Centre, New South Wales
Principal Investigator: Elizabeth L. Hesketh
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Hunter Regional Mail Centre,
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Kamnesh R. Pradhan
Phone: 800-248-1199
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Indianapolis, Indiana 46260
Principal Investigator: Bassem I. Razzouk
Phone: 317-338-2194
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Indianapolis, IN
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Iowa City, Iowa 52242
Principal Investigator: Mariko Sato
Phone: 800-237-1225
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Iowa City, IA
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