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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00445718
  Purpose

RATIONALE: 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.

PURPOSE: This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging.


Condition Intervention
Adrenocortical Carcinoma
Neuroblastoma
Precancerous/Nonmalignant Condition
Procedure: computed tomography
Procedure: magnetic resonance imaging

MedlinePlus related topics:   Cancer    MRI Scans    Neuroblastoma   

Drug Information available for:   Epinephrine    Epinephrine bitartrate   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Perinatal Neuroblastoma: Expectant Observation - A Children's Oncology Group Pilot Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 3-year survival rate

Secondary Outcome Measures:
  • Natural history and histology of disease
  • Tumor biology and histology of prenatal and neonatal neuroblastomas
  • Tumor characteristics associated with a need for resection

Estimated Enrollment:   88
Study Start Date:   March 2005
Estimated Primary Completion Date:   March 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • 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

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

PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior abdominal surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445718

Show 150 study locations  Show 150 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Jed G. Nuchtern, MD     Baylor College of Medicine    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000078643, COG-ANBL00P2
First Received:   March 7, 2007
Last Updated:   October 29, 2008
ClinicalTrials.gov Identifier:   NCT00445718
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
adrenocortical carcinoma  
localized resectable neuroblastoma  
precancerous/nonmalignant condition  

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Precancerous Conditions
Adrenocortical carcinoma
Adrenocortical Carcinoma
Endocrine System Diseases
Adrenal Gland Diseases
Neuroblastoma
Carcinoma
Neuroectodermal Tumors
Adrenal Gland Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Endocrinopathy
Adrenal Cortex Neoplasms
Epinephrine
Adrenal Cortex Diseases
Adenocarcinoma
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on October 31, 2008




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