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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 Various Therapies in Pediatric Patients With Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	20 and under	Other	GPOH-GERMANY-NB97 EU-20102, GER-GPOH-NB97, NCT00017225

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may kill more tumor cells.

Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 21 years old
• No chemotherapy within 6 months after 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 undergo a biopsy. Some patients may undergo observation for 6-12 months. Other patients may undergo second-look surgery and/or combination chemotherapy. Some patients will undergo radiation therapy for up to 6 weeks. Patients may undergo peripheral stem cell transplantation. Some patients may receive tretinoin. All patients will receive follow-up evaluations at 6 weeks, every 3 months for 5 years, and every 6 months thereafter.

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

Gesellschaft fuer Paediatrische Onkologie und Haematologie - Germany

Frank Berthold, MD, Protocol chair		Ph: 49-221-478-4380 Email: frank.berthold@uk-koeln.de

Registry Information
Official Title		Neuroblastoma Study Phase II Study of Various Therapies in Patients with Neuroblastoma
Trial Start Date		1997-05-01
Registered in ClinicalTrials.gov		NCT00017225
Date Submitted to PDQ		2001-04-11
Information Last Verified		2002-08-30

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