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


N/A
N/A
1 Year
Not Enrolling
Both
Adrenocortical Carcinoma, Localized Resectable Neuroblastoma, Precancerous Condition

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Trial Information

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


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 study.

Patients are followed within 1 week and then every 6 months for 3 years.


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

- Negative for neuroblastoma cells by bone marrow aspirate

- No evidence of disease outside the adrenal gland by bone scan (+/-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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Survival rate

Outcome Description:

Estimated using the Kaplan-Meier method.

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Jed Nuchtern

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

ANBL00P2

NCT ID:

NCT00445718

Start Date:

July 2001

Completion Date:

Related Keywords:

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

Name

Location

Baylor College of MedicineHouston, Texas  77030
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Medical City Dallas HospitalDallas, Texas  75230
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Baptist Hospital of MiamiMiami, Florida  33176-2197
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's National Medical CenterWashington, District of Columbia  20010-2970
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Southern California Permanente Medical GroupDowney, California  90242
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
University of RochesterRochester, New York  14642
University of Arizona Health Sciences CenterTucson, Arizona  85724
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
Seattle Children's HospitalSeattle, Washington  98105
Childrens Memorial HospitalChicago, Illinois  60614
Columbia University Medical CenterNew York, New York  10032
Mission Hospitals IncAsheville, North Carolina  28801
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Cook Children's Medical CenterFort Worth, Texas  76104
Advocate Lutheran General HospitalPark Ridge, Illinois  60068
Southern Illinois UniversitySpringfield, Illinois  62702
Alfred I duPont Hospital for ChildrenWilmington, Delaware  19803
Rainbow Babies and Childrens HospitalCleveland, Ohio  44106
East Tennessee Childrens HospitalKnoxville, Tennessee  37916
Saint Joseph's Regional Medical CenterPaterson, New Jersey  07503
Children's Hospital ColoradoAurora, Colorado  80045
Sanford USD Medical Center - Sioux FallsSioux Falls, South Dakota  57117-5134
T C Thompson Children's HospitalChattanooga, Tennessee  37403
Providence Sacred Heart Medical Center and Children's HospitalSpokane, Washington  99204
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, New York  11040