Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

NCT ID: NCT00499616

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 464 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-08
• Study Completion Date: 2021-06-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases.

PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.

Detailed Description

OBJECTIVES:

Primary

• Reduce therapy for patients with intermediate-risk neuroblastoma while maintaining a 3-year overall survival (OS) rate of ≥ 95% by using a response-based duration of therapy algorithm.
• Maintain an overall 3-year OS rate of ≥ 90% for patients within each group.
• Utilize loss of heterozygosity, prospectively, at 1p36 and 11q23 to refine risk-stratification and treatment assignment, allowing patients whose tumors lack these chromosomal abnormalities to receive a reduction in therapy, and compare the outcome with patients treated on COG-A3961.
• Reduce intensity of therapy for patients 365 to < 547 days (12-18 months) of age with stage 4 neuroblastoma and favorable biological features and maintain a 3-year event-free survival (EFS) rate consistent with that for patients < 1 year of age with stage 4 neuroblastoma treated on COG-A3961.
• Reduce intensity of therapy for patients 365 to < 547 days (12-18 months) of age with stage 3 MYCN-nonamplified but unfavorable histology neuroblastoma and maintain a 3-year EFS rate consistent with that for patients < 1 year of age with stage 3, MYCN-nonamplified, unfavorable histology neuroblastoma treated on COG-A3961.
• Reduce surgical morbidity for patients with stage 4S neuroblastoma by allowing for biopsy only, rather than complete surgical resection, of the primary tumor.
• Systematically study the outcome of patients with stage 4S neuroblastoma who are unable to undergo biopsy for biology-based risk assignment.
• Determine if the extent of surgical resection correlates with the maintenance of local control, EFS and/or OS rates, and surgical complication rate.

Secondary

• Determine the results of a standard retrieval approach for patients with residual disease after 8 courses of initial therapy.
• Determine the results of a standard retrieval approach for patients with progressive, nonmetastatic disease.
• Identify additional biological surrogate markers for disease relapse and/or metastatic progression.
• Describe the neurologic outcome of patients with paraspinal neuroblastoma primary tumors.
• Correlate surgical biopsy technique with adequacy of tissue acquisition for biologic studies and with complications associated with the biopsy procedure.
• Prospectively validate the prognostic ability of the International Neuroblastoma Risk Group image-defined risk factor system, and compare the institutional assessment of image-defined risk factors with that of central review.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups by risk-stratification based on age, stage (INSS stage 2, 3, 4, or 4S), MYCN status (amplified vs not amplified), histopathologic classification, tumor DNA index, and allelic status at chromosome bands 11q23 and 1p36.

• Initial chemotherapy: Courses of initial chemotherapy are administered every 21 days according to group assignment as outlined below:

• Course 1: Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
• Course 2: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin hydrochloride IV over 15 minutes on day 1.
• Course 3: Patients receive cyclophosphamide IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
• Course 4: Patients receive carboplatin IV over 1 hour and doxorubicin hydrochloride IV over 15 minutes on day 1 and etoposide IV over 1 hour on days 1-3.
• Course 5: Patients receive cyclophosphamide IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
• Course 6: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin hydrochloride IV over 15 minutes on day 1.
• Course 7: Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
• Course 8: Patients receive cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 15 minutes on day 1.

• Group 2: Patients receive 2 courses of initial chemotherapy. Patients with a partial response (PR) (50-90% reduction in volume) to chemotherapy proceed to observation. Patients without a PR receive 2-6 additional courses of chemotherapy (beginning with course 3). Patients who do not achieve a PR after additional chemotherapy proceed to retrieval chemotherapy.
• Group 3: Patients receive 4 courses of initial chemotherapy. Patients with a PR after chemotherapy proceed to observation. Patients without a PR receive 2-4 additional courses of chemotherapy (beginning with course 5). Patients who do not achieve a PR after additional chemotherapy proceed to retrieval chemotherapy.
• Group 4: Patients receive 8 courses of initial chemotherapy. Patients under 12 months of age with stage 3, 4, or 4S disease who achieve a very good PR (VGPR) (> 90% reduction in the volume of the primary tumor and resolution of metastatic disease, with the exception of liver and skin metastases) to chemotherapy proceed to observation. Patients 12-18 months of age with stage 3 or 4 disease [age 365 to < 547 days at diagnosis, INSS stage 3, MYCN-NA, unfavorable histology, any ploidy and patients age 365 to < 547 days at diagnosis, INSS stage 4, MYCN-NA, favorable histology, DI > 1] who achieve a VGPR proceed to isotretinoin therapy. Patients who do not achieve a VGPR after 8 courses of initial chemotherapy +/- surgery will proceed to retrieval chemotherapy with cyclophosphamide/topotecan for 2-6 courses until a VGPR can be achieved with a combination of chemotherapy and surgery.
• Retrieval chemotherapy*: Patients receive cyclophosphamide IV over 30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses.

• Groups 2 and 3: Patients with a PR after 2-6 courses of retrieval chemotherapy proceed to observation. Patients without a PR after 2-6 courses of retrieval chemotherapy are removed from protocol therapy.
• Group 4: Patients under 12 months of age with stage 4 disease with a VGPR after retrieval chemotherapy proceed to observation. Patients 12-18 months of age with stage 3 or 4 disease who achieve a VGPR after retrieval chemotherapy proceed to isotretinoin therapy. Patients who do not achieve a VGPR after retrieval chemotherapy are removed from protocol therapy.

Group 4 patients who develop progressive, non-metastatic disease within 3 years of study enrollment will also receive retrieval chemotherapy with cyclophosphamide and topotecan.

NOTE: *Patients who have previously received cyclophosphamide and topotecan to achieve first PR/VGPR are not eligible for this Retrieval Therapy.

• Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished. Reassessment for definitive surgery (for patients who undergo biopsy only or partial resection at diagnosis) is made at the completion of scheduled chemotherapy (after course 2 for group 2, after course 4 for group 3, and after course 8 for group 4).
• Isotretinoin therapy: Beginning 3-4 weeks after completion of chemotherapy or 2 weeks post-operatively (for patients who undergo surgical resection), patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for up to 10 years.

Conditions

Neuroblastoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 2 (chemotherapy, surgery)

2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Given IV

cyclophosphamide

Intervention Type: DRUG

Given IV

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

etoposide

Intervention Type: DRUG

Given orally

topotecan hydrochloride

Intervention Type: DRUG

Given IV

Surgery

Intervention Type: PROCEDURE

With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.

Filgrastim

Intervention Type: DRUG

Administered subcutaneously or by IV beginning 24-48 hrs after the last dose of chemotherapy \& continuing daily until the ANC is greater than or equal to 1500 following the myelosuppressive nadir . Supportive care given to stimulate neutrophil recovery following chemotherapy and to shorten the duration of chemotherapy-induced neutropenia. On ANBL0531 the use of filgrastim was required for patients less than 60 days of age and was optional for other patients.

Group 3 (chemotherapy, surgery)

4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Given IV

cyclophosphamide

Intervention Type: DRUG

Given IV

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

etoposide

Intervention Type: DRUG

Given orally

topotecan hydrochloride

Intervention Type: DRUG

Given IV

Surgery

Intervention Type: PROCEDURE

With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.

Filgrastim

Intervention Type: DRUG

Administered subcutaneously or by IV beginning 24-48 hrs after the last dose of chemotherapy \& continuing daily until the ANC is greater than or equal to 1500 following the myelosuppressive nadir . Supportive care given to stimulate neutrophil recovery following chemotherapy and to shorten the duration of chemotherapy-induced neutropenia. On ANBL0531 the use of filgrastim was required for patients less than 60 days of age and was optional for other patients.

Group 4 (chemotherapy, surgery, antineoplastic therapy)

8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Given IV

cyclophosphamide

Intervention Type: DRUG

Given IV

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

etoposide

Intervention Type: DRUG

Given orally

topotecan hydrochloride

Intervention Type: DRUG

Given IV

Isotretinoin

Intervention Type: DRUG

Given orally

Surgery

Intervention Type: PROCEDURE

With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.

Filgrastim

Intervention Type: DRUG

Administered subcutaneously or by IV beginning 24-48 hrs after the last dose of chemotherapy \& continuing daily until the ANC is greater than or equal to 1500 following the myelosuppressive nadir . Supportive care given to stimulate neutrophil recovery following chemotherapy and to shorten the duration of chemotherapy-induced neutropenia. On ANBL0531 the use of filgrastim was required for patients less than 60 days of age and was optional for other patients.

Non-intermediate risk enrolled on intermediate risk trial

The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.

Interventions

carboplatin

Given IV

Intervention Type: DRUG

cyclophosphamide

Given IV

Intervention Type: DRUG

doxorubicin hydrochloride

Given IV

Intervention Type: DRUG

etoposide

Given orally

Intervention Type: DRUG

topotecan hydrochloride

Given IV

Intervention Type: DRUG

Isotretinoin

Given orally

Intervention Type: DRUG

Surgery

With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.

Intervention Type: PROCEDURE

Filgrastim

Administered subcutaneously or by IV beginning 24-48 hrs after the last dose of chemotherapy \& continuing daily until the ANC is greater than or equal to 1500 following the myelosuppressive nadir . Supportive care given to stimulate neutrophil recovery following chemotherapy and to shorten the duration of chemotherapy-induced neutropenia. On ANBL0531 the use of filgrastim was required for patients less than 60 days of age and was optional for other patients.

Intervention Type: DRUG

Other Intervention Names

Paraplatin; NSC #241240; Cytoxan; NSC #26271; Adriamycin; NSC #123127; VePesid; VP-16; NSC #141540; SKF-104864; Hycamtin; NSC #60969; 13-cis-retinoic acid; RO-43; 780; Accutane; Amnesteem; Claravis; Sotret; NSC#329481; Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC #614629

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/maturing subtype

• Newly diagnosed disease
• Intermediate-risk disease
• Needle biopsies or involved bone marrow are not sufficient for INPC histologic classification
• Meets 1 of the following criteria:

• Group 2

• International Neuroblastoma Staging System (INSS) stage 2A/2B; < 50% resected or biopsy only; ≤ 12 years of age; MYCN-not amplified (NA); any histology and ploidy; normal 1p and 11q
• INSS stage 3; age < 365 days; MYCN-NA; favorable histology (FH); hyperdiploid (DI) > 1; normal 1p and 11q
• INSS stage 3; 365 days to 12 years of age; MYCN-NA; FH; normal 1p and 11q
• INSS stage 4S; age < 365 days; MYCN-NA; FH; DI >1; normal 1p and 11q; clinically symptomatic
• Group 3

• INSS stage 2A/2B; < 50% resected or biopsy only; ≤ 12 years of age; MYCN-NA; any histology and ploidy; 1p loss of heterozygosity (LOH) and/or unb11q LOH (or data missing for either)
• INSS stage 3; age < 365 days; MYCN-NA; FH; DI > 1; 1p LOH and/or unb11q LOH (or data missing for either)
• INSS stage 3; age < 365 days; MYCN-NA; DI = 1 and/or unfavorable histology (UH); normal 1p and 11q
• INSS stage 3; 365 days to 12 years of age; MYCN-NA; FH; 1p LOH and/or unb11q LOH (or data missing for either)
• INSS stage 4; age < 365 days; MYCN-NA; FH; DI > 1; normal 1p and 11q
• INSS stage 4S; age < 365 days; MYCN-NA; either UH and any ploidy or FH and DI = 1; normal 1p and 11q
• INSS stage 4S; age < 365 days; MYCN-NA; FH; DI > 1; 1p LOH and/or unb11q LOH (or data missing for either); clinically symptomatic
• Group 4

• INSS stage 3; age < 365 days; MYCN-NA; DI = 1 and/or UH; 1p LOH and/or unb11q LOH (or data missing for either)
• INSS stage 3; age 365 to < 547 days; MYCN-NA; UH; any ploidy; any 1p and 11q
• INSS stage 4, age < 365 days; MYCN-NA; DI = 1 and/or UH; any 1p and 11q
• INSS stage 4; age < 365 days; MYCN-NA; FH; DI > 1; 1p LOH and/or unb11q LOH (or data missing for either)
• INSS stage 4; age 365 to < 547 days; MYCN-NA; FH; DI > 1; any 1p and 11q
• INSS stage 4S; age < 365 days; MYCN-NA; UH and any ploidy or FH and DI = 1; 1p LOH and/or unb11q LOH (or data missing for either)
• INSS stage 4S; age < 365 days; unknown or incomplete biologic features

8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim.

Patients < 12 months of age with stg 3, 4, or 4S disease who achieve a very good PR (VGPR) to chemo (with the exception of resolution of skin or liver metastases in stage 4S patients) proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

• Must already be enrolled on protocol COG-ANBL00B1

• Simultaneous enrollment on COG-ANBL00B1 and this study allowed for clinical situations in which emergent treatment may be indicated including, but not limited to, the following criteria:

• 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 (e.g., abdominal compartment syndrome, urinary obstruction)
• Asymptomatic but, in the opinion of the treating physician, it is in the patient's best interest to begin chemotherapy immediately due to impending risk of neurologic impairment or organ dysfunction
• If patient receives study chemotherapy prior to undergoing diagnostic biopsy, the biopsy must be performed within 96 hours of beginning study therapy

• The only exception to this requirement is for patients with stage 4S disease who are considered too ill to undergo a diagnostic procedure will be waived the requirement for diagnostic tissue submission but will still need to be enrolled on COG-ANBL00B1

• For patients with stage 4S disease who are very ill and in whom an open biopsy to obtain tissue for diagnosis and biologic studies is considered medically contraindicated, every effort should be made to obtain some tumor tissue by either fine-needle aspiration of a metastatic site of disease and/or sampling of involved bone marrow, so that this tumor sample can be submitted for MYCN determination
• Patients who require emergent therapy, either prior to the diagnostic biopsy or before biology features are available, can be enrolled simultaneously on COG-ANBL00B1 and COG-ANBL0531 to receive emergent protocol therapy

• In emergent circumstances, COG-ANBL0531 protocol therapy may be initiated prior to enrollment on study as long as the patient has neuroblastoma by clinical diagnosis, all other COG-ANBL0531 eligibility criteria are met, and the COG-ANBL0531 Initial Therapy consent has been signed prior to starting protocol therapy; in this circumstance ANBL0531 enrollment must occur within 4 working days of starting protocol therapy
• Clinical situations in which emergent enrollment and treatment may be indicated include, but are not limited to, the following circumstances:

• 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 (e.g., abdominal compartment syndrome, urinary obstruction)
• Evolving hepatomegaly in infants less than 2 months of age

PATIENT CHARACTERISTICS:

• See Disease Characteristics

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No other prior chemotherapy or radiotherapy with the exception of dexamethasone
• No participation in another COG study with tumor therapeutic intent

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clare Twist, MD

Role: STUDY_CHAIR

Lucile Packard Children's Hospital at Stanford University Medical Center

Mary Lou Schmidt, MD

Role: STUDY_CHAIR

University of Illinois at Chicago

Locations

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Southern California Permanente Medical Group

Downey, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, United States

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, United States

Childrens Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Central California

Madera, California, United States

Children's Hospital and Research Center Oakland

Oakland, California, United States

Children's Hospital of Orange County

Orange, California, United States

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, United States

Sutter Cancer Center

Sacramento, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

Kaiser Permanente Medical Center - Oakland

Sacramento, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Children's Hospital Center for Cancer and Blood Disorders

Aurora, Colorado, United States

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, United States

Lee Cancer Care of Lee Memorial Health System

Fort Myers, Florida, United States

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Baptist-South Miami Regional Cancer Program

Miami, Florida, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Nemours Children's Clinic - Orlando

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

All Children's Hospital

St. Petersburg, Florida, United States

St. Joseph's Cancer Institute at St. Joseph's Hospital

Tampa, Florida, United States

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, United States

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Atlanta, Georgia, United States

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Tripler Army Medical Center

Tripler AMC, Hawaii, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Children's Memorial Hospital - Chicago

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Oak Lawn, Illinois, United States

Advocate Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Simmons Cooper Cancer Institute

Springfield, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Blank Children's Hospital

Des Moines, Iowa, United States

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Kosair Children's Hospital

Louisville, Kentucky, United States

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, United States

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, United States

Maine Children's Cancer Program at Barbara Bush Children's Hospital

Scarborough, Maine, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Floating Hospital for Children at Tufts - New England Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

C.S. Mott Children's Hospital at University of Michigan Medical Center

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

University of Mississippi Cancer Clinic

Jackson, Mississippi, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Children's Hospital

Omaha, Nebraska, United States

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, United States

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, United States

Overlook Hospital

Morristown, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Albany Medical Center Hospital

Albany, New York, United States

Maimonides Cancer Center at Maimonides Medical Center

Brooklyn, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Winthrop University Hospital

Mineola, New York, United States

Schneider Children's Hospital

New Hyde Park, New York, United States

NYU Cancer Institute at New York University Medical Center

New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, United States

New York Medical College

Valhalla, New York, United States

Mission Hospitals - Memorial Campus

Asheville, North Carolina, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Dayton Children's - Dayton

Dayton, Ohio, United States

Toledo Hospital

Toledo, Ohio, United States

Mercy Children's Hospital

Toledo, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Legacy Emanuel Hospital and Health Center and Children's Hospital

Portland, Oregon, United States

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, United States

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, United States

Greenville Hospital Cancer Center

Greenville, South Carolina, United States

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, United States

T.C. Thompson Children's Hospital

Chattanooga, Tennessee, United States

East Tennessee Children's Hospital

Knoxville, Tennessee, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Amarillo, Texas, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, United States

Baylor University Medical Center - Houston

Houston, Texas, United States

Covenant Children's Hospital

Lubbock, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

CCOP - Scott and White Hospital

Temple, Texas, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Carilion Medical Center for Children at Roanoke Community Hospital

Roanoke, Virginia, United States

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, United States

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center - Tacoma

Tacoma, Washington, United States

Madigan Army Medical Center - Tacoma

Tacoma, Washington, United States

West Virginia University Health Sciences Center - Charleston

Charleston, West Virginia, United States

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Children's Hospital at Westmead

Westmead, New South Wales, Australia

Royal Children's Hospital

Brisbane, Queensland, Australia

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Alberta Children's Hospital

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Children's Hospital of Western Ontario

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Hospital for Sick Children

Toronto, Ontario, Canada

Hopital Sainte Justine

Montreal, Quebec, Canada

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Centre Hospitalier Universitaire de Quebec

Québec, , Canada

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, , Netherlands

Starship Children's Health

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

San Jorge Children's Hospital

Santurce, , Puerto Rico

Countries

United States; Australia; Canada; Netherlands; New Zealand; Puerto Rico

References

Twist CJ, Schmidt ML, Naranjo A, London WB, Tenney SC, Marachelian A, Shimada H, Collins MH, Esiashvili N, Adkins ES, Mattei P, Handler M, Katzenstein H, Attiyeh E, Hogarty MD, Gastier-Foster J, Wagner E, Matthay KK, Park JR, Maris JM, Cohn SL. Maintaining Outstanding Outcomes Using Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma: A Report From the Children's Oncology Group Study ANBL0531. J Clin Oncol. 2019 Dec 1;37(34):3243-3255. doi: 10.1200/JCO.19.00919. Epub 2019 Aug 6.

Reference Type: DERIVED

PMID: 31386611 (View on PubMed)

Twist CJ, Naranjo A, Schmidt ML, Tenney SC, Cohn SL, Meany HJ, Mattei P, Adkins ES, Shimada H, London WB, Park JR, Matthay KK, Maris JM. Defining Risk Factors for Chemotherapeutic Intervention in Infants With Stage 4S Neuroblastoma: A Report From Children's Oncology Group Study ANBL0531. J Clin Oncol. 2019 Jan 10;37(2):115-124. doi: 10.1200/JCO.18.00419. Epub 2018 Nov 16.

Reference Type: DERIVED

PMID: 30444686 (View on PubMed)

Related Links

https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

https://pubmed.ncbi.nlm.nih.gov/31386611/

Maintaining Outstanding Outcomes Using Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma: A Report From the Children's Oncology Group Study ANBL0531

Other Identifiers

COG-ANBL0531

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-00400

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL0531

Identifier Type: -

Identifier Source: org_study_id