Surgery in Treating Children With Neuroblastoma
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003119
First received: November 1, 1999
Last updated: June 14, 2012
Last verified: November 2010
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Purpose
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.
PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
neuroblastoma
Drug Information available for:
Cyclophosphamide
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Carboplatin
Etoposide phosphate
Filgrastim
Sargramostim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | March 1998 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven low-risk neuroblastoma (excluding ganglioneuroma)
- International Neuroblastoma Staging System (INSS) stage 1 in all patients
- INSS stage 2A or 2B in patients less than 365 days of age
- INSS stage 2A or 2B tumor with nonamplified MYCN with any Shimada histology in patients ages 1 to 20 years
- INSS stage 2A or 2B tumor with amplified MYCN with Shimada favorable histology in patients ages 1 to 20 years
- INSS stage 4S tumors with nonamplified MYCN, Shimada favorable histology, and a DNA index not equal to 1 in patients less than 365 days of age
Immediate chemotherapy allowed prior to biopsy for patients with intradural extension and/or emergent paresis if biopsy performed within 96 hours
- Must have no abnormal organ function unless due to neuroblastoma
- Concurrent registration on companion biology study (protocol COG-ANBL00B1) or its successor
PATIENT CHARACTERISTICS:
Age:
- Under 21
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 1.5 times normal
- SGOT or SGPT less than 2.5 times normal
Renal:
- Creatinine less than 1.5 times normal
Cardiovascular:
- Shortening fraction greater than 27% by echocardiogram OR
- Ejection fraction greater than 47% by radionuclide angiogram
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- No prior hormonal therapy
Radiotherapy:
- No prior radiotherapy
Surgery:
- Prior surgery allowed
Other:
- No other prior therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003119
Show 235 Study Locations
Show 235 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Douglas R. Strother, MD | Alberta Children's Hospital |
More Information
Additional Information:
Publications:
Attiyeh EF, Mosse YP, Diskin S, et al.: Identification of genomic DNA signatures predicting relapse in low- and intermediate- risk neuroblastoma using a case control design and high-density SNP genotyping: a Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9500, 526s, 2007.
| ClinicalTrials.gov Identifier: | NCT00003119 History of Changes |
| Other Study ID Numbers: | CDR0000065874, COG-P9641, POG-P9641, CCG-P9641 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
localized resectable neuroblastoma stage 4S neuroblastoma |
Additional relevant MeSH terms:
|
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Cyclophosphamide Doxorubicin Etoposide Carboplatin Lenograstim |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 21, 2013