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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Etoposide and Carboplatin and Cyclophosphamide, Doxorubicin, and Vincristine Followed By Surgery in Infants With Newly Diagnosed Stage IV Neuroblastoma Without MYCN Amplification

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Under 12 months at diagnosis	Other	EURO-INF-NB-STUDY-1999-99.3 EU-20125C, NCT00025623

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.

Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 1 year old at diagnosis
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive infusions of a combination chemotherapy regimen for 3 days every 3 weeks for two or four courses. Some patients will then undergo surgery to remove the tumor. Other patients will receive infusions of a different chemotherapy regimen for 5 days every 3 weeks for two or four courses. Some of these patients will then undergo surgery to remove the tumor. All patients will be evaluated within 6 months and then once a year for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

European Infant Neuroblastoma Study 1999 Group

Bruno De Bernardi, MD, Protocol chair		Ph: 39-10-563-6464 Email: brunodebernardi@ospedale-gaslini.ge.it

Registry Information
Official Title		European Infant Neuroblastoma Study - Stage 4 with Bone, Lung, Pleura or CNS Involvement; MYCN not Amplified
Trial Start Date		1999-07-01
Registered in ClinicalTrials.gov		NCT00025623
Date Submitted to PDQ		2001-08-28
Information Last Verified		2002-12-24

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