Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 30
Updated:8/9/2018
Start Date:November 6, 2000

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Neuroblastoma Biology Studies

This research trial studies biomarkers in tumor tissue samples from patients with newly
diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from
patients with cancer in the laboratory may help doctors identify and learn more about
biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To prospectively analyze the factors that are currently used for risk-group assignment
(v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog [MYCN] copy number
by fluorescent in situ hybridization [FISH], deoxyribonucleic acid [DNA] content by flow
cytometry, and tumor histology using the International Neuroblastoma Pathologic
Classification System) in neuroblastoma tumors at the time of diagnosis.

II. To maintain a reference bank containing clinically and genetically characterized frozen
tumor tissue, tumor DNA and ribonucleic acid (RNA), histology slides and paraffin blocks,
neuroblastoma-derived cell lines, patient serum and paired normal DNA obtained at the time of
diagnosis, at the time of second-look surgery and at the time of relapse for future research
studies.

III. To prospectively analyze 1p, 11q, 14q and 17q allelic status, MYCN copy number by
quantitative polymerase chain reaction (PCR); and the expression pattern of
neurotrophin-related genes in diagnostic neuroblastoma tumors, and assay for the presence of
rare tumor cells in biological specimens by reverse transcription (RT)-PCR; these biological
variables will be analyzed for independent clinical significance compared to MYCN
amplification, International Neuroblastoma Staging System (INSS) stage, age, ploidy, and
histologic variables in predicting either response to treatment or outcome.

IV. To build a database of the known biologic prognostic factors for patients on therapeutic
studies.

V. To serve as a Registry for neuroblastoma patients whose tumors demonstrate clinical and
genetic features defined as ?Low Risk? for treatment failure in the absence of adjuvant
therapy.

SECONDARY OBJECTIVES:

I. To prospectively analyze the concordance between detection of MYCN amplification in tumor
samples and quantitative detection of MYCN DNA in serum, and to analyze the prognostic
significance of MYCN amplification as detected in serum samples.

II. To build a database that includes information regarding the presentation and natural
history of neuroblastoma-associated health problems including but not limited to opsoclonus
myoclonus ataxia (OMA) and/or spinal cord compression.

OUTLINE:

Patients undergo collection of blood, tissue, and bone marrow samples for analysis via
RT-PCR, quantitative PCR, flow cytometry, and FISH.

After completion of study, patients are followed up periodically.

Inclusion Criteria:

- All newly diagnosed patients with suspected neuroblastoma, suspected
ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's
Oncology Group (COG) institutions are eligible for this study

- There will be no penalty under any circumstances for enrollment of a patient
whose definitive institutional diagnosis, or central review diagnosis, is found
to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/
maturing subtype

- Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and
procurement of study-related tissues with the following exception:

- Patients that in the opinion of the treating physician are too ill to undergo
pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on
ANBL00B1; documentation of the emergent nature of therapy initiation is required

- It is required that a good faith effort (documented by specimen tracking) be made to
submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow)
of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in
order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be
obtained prior to initiation of therapy

- Exceptions

- In rare cases, patients may be deemed too ill to undergo pre-treatment tissue
biopsy and require EMERGENT therapy; the following eligibility guidelines apply
to these cases:

- For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g.,
primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT
therapy initiation should be made; however, if the child is deemed too
unstable for such a procedure they may still be enrolled as long as
pre-treatment peripheral blood and serum have been submitted

- For all other INSS stages: tumor tissue should be obtained as soon as
possible within 96 hours of EMERGENT therapy initiation; patients without
tumor tissues submitted within this time-frame are not eligible for
enrollment

- Note: it may not be possible to obtain all necessary tumor biomarkers
for therapy stratification in such cases; if a patient enrolled on
ANBL00B1 undergoes an additional diagnostic procedure within 96 hours
of initiating therapy, additional tumor specimens may be submitted to
obtain biomarkers used for risk classification; the decision to perform
such procedures, and/or submit these specimens, is to be made by the
managing clinicians and should reflect the clinical need to know the
status of such biomarkers

- Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a
tumor biopsy or resection upfront; tumor tissue submission is therefore not
required for these patients to enroll on ANBL00B1; a peripheral blood and
serum sample is the only specimen required to be submitted for this group of
patients; should they undergo a biopsy or resection at a later date tumor
can be submitted for biomarker testing at this time

- 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 relapsed neuroblastoma who were not enrolled on ANBL00B1 at original
diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1
protocol
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Charleston, SC
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3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
Principal Investigator: Ashley E. Meyer
Phone: 304-388-9944
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Charleston, WV
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Charlotte, North Carolina 28204
Principal Investigator: Jessica A. Bell
Phone: 704-384-5369
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Charlotte, NC
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Charlotte, North Carolina 28204
Principal Investigator: Joel A. Kaplan
Phone: 704-355-2884
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Charlotte, NC
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Chattanooga, Tennessee 37403
Principal Investigator: Manoo G. Bhakta
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Chattanooga, TN
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Chicago, Illinois 60614
Principal Investigator: Jennifer L. Reichek
Phone: 773-880-4562
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from
Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Michael D. Hogarty
Phone: 215-590-3931
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Mary L. Schmidt
Phone: 312-355-3046
Univ of Illinois A major research university in the heart of one of the world's...
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Susan L. Cohn
Phone: 773-702-8222
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Aron Flagg
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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from
Cleveland, OH
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Columbia, Missouri 65201
Principal Investigator: Barbara A. Gruner
Phone: 573-882-7440
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from
Columbia, MO
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1 Hospital Dr
Columbia, Missouri 65212
(573) 882-2100
University of Missouri-Ellis Fischel Ellis Fischel Cancer Center's team of physician specialists and other trained...
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Columbia, MO
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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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Columbia, SC
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Dallas, Texas 75390
Principal Investigator: Tanya C. Watt
Phone: 214-648-7097
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from
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
Phone: 800-228-4055
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from
Dayton, OH
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Denver, Colorado 80218
Principal Investigator: Michael D. Hogarty
Phone: 215-590-3931
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from
Denver, CO
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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: Zhihong J. Wang
Phone: 313-576-9790
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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from
Detroit, MI
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Michael D. Hogarty
Phone: 215-590-3931
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Principal Investigator: Adonis N. Lorenzana
Phone: 734-712-3671
Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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Detroit, MI
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9333 Imperial Highway
Downey, California 90242
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Downey, CA
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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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from
East Lansing, MI
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