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Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002803
Recruitment Status : Completed
First Posted : May 12, 2004
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove the tumor may kill more tumor cells.

PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: vincristine sulfate Procedure: conventional surgery Phase 2

Detailed Description:

OBJECTIVES: I. Determine the incidence of spontaneous regression of localized neuroblastoma in infants. II. Determine how many infants with neuroblastoma do not need chemotherapy. III. Evaluate the time course of regression by radiologic criteria and catecholamine metabolites. IV. Determine the reliability of risk estimation by molecular characteristics (N-myc amplification, CD44, del 1p) compared to clinical criteria. V. Evaluate whether reduced therapeutic toxicity results in a decrease in treatment-related deaths. VI. Correlate cytostatic drug levels with chemotherapy side effects.

OUTLINE: All patients undergo resection of the primary tumor and N-myc determination within 6 months of age, unless critically ill, then are treated according to risk. Patients with amplified N-myc or with indeterminate N-myc amplification but with other risk features are treated per protocol GER-NB90. Stage 4S patients who are critically ill or thrombocytopenic receive doxorubicin, vincristine, and cyclophosphamide over 7 days. Patients with no amplification of N-myc are observed for 6 months (until between 12 and 18 months of age). Patients with minimal residual disease (less than 10% or diameter no greater than 2-5 mm) continue observation, while those with residual disease but no disease progression undergo repeat biopsy. Patients whose biopsy indicates tumor regression also continue observation. All other patients, including those with disease progression, are treated per protocol GER-NB90.

PROJECTED ACCRUAL: 36-44 patients per year will be accrued (22-27 patients with stages 1-3, 8-10 patients with stage 4S, and 6-7 patients with stage 4 neuroblastoma).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Primary Purpose: Treatment
Study Start Date : July 1995
Actual Study Completion Date : February 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002803

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University of Cologne
Frechen, Germany, DOH-5-0226
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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Study Chair: Frank Berthold, MD Children's Hospital Medical Center, Cincinnati
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00002803    
Other Study ID Numbers: CDR0000064903
First Posted: May 12, 2004    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: April 2008
Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma
Additional relevant MeSH terms:
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Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents