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

Alternate Title

Phase I Study of Monoclonal Antibody Ch14.18 Combined With Sargramostim (GM-CSF) and Interleukin-2 After Autologous Bone Marrow or Peripheral Blood Stem Cell Rescue in Children With Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	21 and under	NCI	COG-A0935A CCG-0935, CCG-0935A, NCT00005576

Trial Description

Purpose:

Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor cells.

Phase I trial to study the effectiveness of monoclonal antibody therapy given with sargramostim and interleukin-2 in treating children with neuroblastoma who have just completed bone marrow or peripheral stem cell transplantation.

Eligibility:

• Younger than 22 years old
• At least 2 weeks since chemotherapy or corticosteroid therapy
• 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 up to five courses of treatment. They will receive a 5-hour infusion of monoclonal antibody 4 days a week for 2 weeks of each course. They will also receive a 2-hour infusion or injections of sargramostim for 2 weeks of courses one, three, and five. They will receive a 4-day continuous infusion of interleukin-2 for 2 weeks of courses two and four, and isotretinoin by mouth twice a day for 2 weeks of courses two through four. Patients will be evaluated every other week for 2 months and every 3 months for 6 months.

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

Children's Oncology Group

Andrew Gilman, MD, Protocol chair(Contact information may not be current)		Ph: 816-234-3265 Email: agilman@cmh.edu

Registry Information
Official Title		A PHASE I STUDY OF CHIMERIC HUMAN/MURINE ANTI-GD2 MONOCLONAL ANTIBODY (ch14.18) WITH GM-CSF IN CHILDREN WITH NEUROBLASTOMA AND OTHER GD2 POSITIVE MALIGNANCIES IMMEDIATELY POST AUTOLOGOUS BMT
Trial Start Date		2001-01-11
Registered in ClinicalTrials.gov		NCT00005576
Date Submitted to PDQ		1994-05-27
Information Last Verified		2008-12-11
NCI Grant/Contract Number		CA57746

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