Clinical Research for patients with neuroblastoma


14593

Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

Pediatrics

Dunsmore Kimberly, P

UVa Health System, Department of Pediatrics seeks: children, adolescents, women and men with neuroblastoma, and categorized as high risk at the time of diagnosis. The patient must be less than 40 years old at the time of enrollment. The standard treatment for neuroblastoma consists of anti-cancer drugs (chemotherapy), surgery, stem cell transplant and radiation therapy. At the end of this intensive treatment, it is standard for children with high risk neuroblastoma to take another anti-cancer drug. Children with high-risk neuroblastoma often respond to standard treatment at first, but there is a high risk that the cancer will come back. The purpose of the study is to try and improve the likelihood that the cancer will not come back in these children. This study is looking at whether adding a monoclonal antibody, ch14.18 and cytokines (GM-CSF and IL-2) to the standard maintenance treatment of isotretinoin will improve patient outcomes. Early results from this study show that the experimental treatment, which includes the drugs ch14.18, GM-CSF and IL-2 works better than standard treatment to help get rid of any remaining neuroblastoma cells. All patients enrolled on this study will receive the investigational treatment. The study involves taking the experimental drug ch14.18, FDA approved chemotherapy agents, blood draws, physical exams, urinalyses, bone marrow biopsy (in certain situations), pregnancy test (for females of child bearing age), CT/MRI and bone scans. Compared to standard treatment which only requires outpatient visits, this study requires 5 in-patient visits in addition to the standard outpatient visits. The inpatient admissions will occur over approximately 17 weeks. Each in-patient visit will be scheduled to last 4 days. Data will be collected until subjects enter another study sponsored by the Childrens Oncology Group (COG). Two of the drugs, ch14.18 and GM-CSF, will be provided free of charge You and/or your insurance will be billed for all other study related medication, tests, treatment, and procedures. No compensation is provided for this study. Contact Information: For more information please contact: " Candace Hudspeth, CCRC " Tel: 434-982-1091 Email: ckh3k@virginia.edu " IRB-HSR # 14593 (COG ANBL0032) Principal Investigator: Kimberly P. Dunsmore, MD

Hematology/Oncology

Adult
Child

Pediatric Cancers: Neuroblastoma

Pediatrics
Cancer (Oncology)

Ill


Candy Hudspeth

ckh3k@virginia.edu

4349821091