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

Precancerous Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445718
• Other study ID #: ANBL00P2
• Secondary ID: NCI-2009-00398CO
• Status: Completed
• Phase: N/A
• First received: March 7, 2007
• Last updated: February 7, 2017
• Start date: July 2001
• Est. completion date: January 2013

Study information

• Verified date: February 2017
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Localized Resectable Neuroblastoma
• Neuroblastoma
• Precancerous Condition
• Precancerous Conditions

Intervention

Procedure:
• computed tomography

• 3-Tesla magnetic resonance imaging

• Abdominal Sonogram
Sonogram of the abdomen area

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Parkville	Victoria
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Chedoke-McMaster Hospitals	Hamilton	Ontario
Canada	Hospital Sainte-Justine	Montreal	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Centre Hospitalier Universitaire de Quebec	Ste-Foy	Quebec
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Mission Hospitals Inc	Asheville	North Carolina
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Brooklyn Hospital Center	Brooklyn	New York
United States	T C Thompson Children's Hospital	Chattanooga	Tennessee
United States	Childrens Memorial Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Rainbow Babies and Childrens Hospital	Cleveland	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Southern California Permanente Medical Group	Downey	California
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Saint Vincent Hospital	Green Bay	Wisconsin
United States	Baylor College of Medicine	Houston	Texas
United States	East Tennessee Childrens Hospital	Knoxville	Tennessee
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Baptist Hospital of Miami	Miami	Florida
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	The Steven and Alexandra Cohen Children's Medical Center of New York	New Hyde Park	New York
United States	Columbia University Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Saint Joseph's Regional Medical Center	Paterson	New Jersey
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	University of Rochester	Rochester	New York
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Maine Children's Cancer Program	Scarborough	Maine
United States	Seattle Children's Hospital	Seattle	Washington
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	Southern Illinois University	Springfield	Illinois
United States	University of Arizona Health Sciences Center	Tucson	Arizona
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I duPont Hospital for Children	Wilmington	Delaware
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	Estimated using the Kaplan-Meier method.	Up to 3 years
Primary	Event-free survival (EFS)	Estimated using the Kaplan-Meier method.	Up to 3 years