Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging

Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study

This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging. Gathering information over time from imaging and laboratory tests of infants with adrenal masses may help doctors learn more about the disease and plan the best treatment.

Study Overview

• Status: Completed
• Conditions: Precancerous Condition; Adrenocortical Carcinoma; Localized Resectable Neuroblastoma
• Intervention / Treatment: Procedure: computed tomography; Procedure: 3-Tesla magnetic resonance imaging; Procedure: Abdominal Sonogram

Detailed Description

PRIMARY OBJECTIVE:

I. Determine whether nonoperative management of infants with adrenal masses found on prenatal and/or neonatal imaging results in a 3-year survival rate of 95%.

SECONDARY OBJECTIVES:

I. Estimate the percentage of these patients who are spared surgical resection. II. Evaluate the natural history and histology of perinatal adrenal masses. III. Evaluate the tumor biology and histology of prenatal and neonatal neuroblastomas.

IV. Determine the tumor characteristics that are associated with a need for resection.

OUTLINE:

Patients undergo an abdominal CT or MRI scan on weeks 0, 6, and 42 and an abdominal sonogram on weeks 0, 3, 6, 12, 18, 30, 42, 66, and 90. Urinary catecholamine levels are also measured on the same weeks as the abdominal sonogram. Patients with an increase in tumor volume or catecholamine levels undergo sonographic evaluation and urine catecholamine sampling every 3 weeks until stabilization. Patients with a continued increase in catecholamine levels or a 50% increase in tumor volume undergo surgical resection off protocol therapy.

After a patient goes off-observation, they will be monitored every six months for two years, and annually thereafter.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3J 3G9
      • IWK Health Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • Chedoke-McMaster Hospitals
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Hospital Sainte-Justine
    • Ste-Foy, Quebec, Canada, G1V 4G2
      • Centre Hospitalier Universitaire de Quebec
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Health Sciences Center
  • California
    • Downey, California, United States, 90242
      • Southern California Permanente Medical Group
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I duPont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Childrens Memorial Hospital
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Children's Cancer Program
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Paterson, New Jersey, United States, 07503
      • Saint Joseph's Regional Medical Center
  • New York
    • Brooklyn, New York, United States, 11201
      • Brooklyn Hospital Center
    • New Hyde Park, New York, United States, 11040
      • The Steven and Alexandra Cohen Children's Medical Center of New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospitals Inc
  • Ohio
    • Akron, Ohio, United States, 44308
      • Children's Hospital Medical Center of Akron
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44106
      • Rainbow Babies and Childrens Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117-5134
      • Sanford USD Medical Center - Sioux Falls
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • T C Thompson Children's Hospital
    • Knoxville, Tennessee, United States, 37916
      • East Tennessee Childrens Hospital
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center
  • Virginia
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center - Portsmouth
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center and Children's Hospital
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with sonographically identified adrenal mass

Description

Inclusion Criteria:

• Sonographically identified adrenal mass meeting one of the following criteria:

  • No greater than 16 mL in volume, if solid
  • No greater than 65 mL if at least 25% cystic and does not cross the midline

• Disease limited to the adrenal gland

  • No evidence of positive contralateral or ipsilateral lymph nodes or other spread outside the adrenal gland by CT scan or MRI
  • No evidence of disease outside the adrenal gland by MIBG scan
  • Negative for tumor cells by bone marrow biopsy, if performed
• No more than 6 months of age on the date the mass is first identified
• No prior chemotherapy
• No prior abdominal surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational; Patients undergo an abdominal CT or MRI scan on weeks 0, 6, and 42 and an abdominal sonogram on weeks 0, 3, 6, 12, 18, 30, 42, 66, and 90. Urinary catecholamine levels are also measured on the same weeks as the abdominal sonogram. Patients with an increase in tumor volume or catecholamine levels undergo sonographic evaluation and urine catecholamine sampling every 3 weeks until stabilization. Patients with a continued increase in catecholamine levels or a 50% increase in tumor volume undergo surgical resection off protocol therapy.

Procedure: computed tomography; Other Names: tomography, computed; Procedure: 3-Tesla magnetic resonance imaging; Other Names: 3T MRI; 3-Tesla MRI; Procedure: Abdominal Sonogram; Sonogram of the abdomen area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Estimated using the Kaplan-Meier method.	Up to 3 years
Event-free survival (EFS)	Estimated using the Kaplan-Meier method.	Up to 3 years

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jed Nuchtern, MD, Children's Oncology Group

Publications and helpful links

General Publications

• Nuchtern JG, London WB, Barnewolt CE, Naranjo A, McGrady PW, Geiger JD, Diller L, Schmidt ML, Maris JM, Cohn SL, Shamberger RC. A prospective study of expectant observation as primary therapy for neuroblastoma in young infants: a Children's Oncology Group study. Ann Surg. 2012 Oct;256(4):573-80. doi: 10.1097/SLA.0b013e31826cbbbd.

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: March 7, 2007
• First Submitted That Met QC Criteria: March 7, 2007
• First Posted (Estimate): March 9, 2007

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Neuroblastoma; Precancerous Conditions; Adrenocortical Carcinoma
• Other Study ID Numbers: ANBL00P2; U10CA098543 (U.S. NIH Grant/Contract); NCI-2009-00398 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); COG-ANBL00P2 (Other Identifier: Children's Oncology Group)