Protocol

NBIMRT: A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) In High-Risk Abdominal Neuroblastoma

Diseases

Solid Tumor : High risk abdominal neuroblastoma

Description

Neuroblastoma commonly develops in nerve cells outside of the brain. Neuroblastoma shows up as a lump or mass most frequently in the belly but also in the neck, chest, abdomen or pelvis. It often spreads to bone, lymph nodes, liver and bone marrow (the soft tissue in the center of bones where blood cells are made). In high risk neuroblastoma patients, tumor has either spread from where it started or is harder to treat because it has special characteristics making it behave more aggressively. The standard treatment for patients with high-risk abdominal neuroblastoma is a combination of chemotherapy (drugs), surgery, bone marrow transplant, radiation therapy and immunotherapy (treatment using antibodies to get rid of cancer in the body).

The purpose of this study is to learn what impact breathing has on the motion of the area where the tumor was/is and also the kidneys which are often situated right next to the original tumor site. One part of the study is to measure different types of motion with breathing by using an elastic band with a pressure sensor placed around the abdomen to estimate what is happening with each breath. The elastic band measures how much the wall of the abdomen moves with each breath, and this gives the study team a way to estimate how the diaphragm and other normal organs within the belly move. By looking at this motion, the study team will have a better ability to predict how things in the patient belly move, and they can do a better job of reducing harmful radiation dose to normal tissues like the kidneys, while increasing the amount of dose delivered to the areas that need it.

A retrospective review of patients treated with these methods yielded zero failures in 20 kids after almost 2 years of follow-up.

The standard of care radiation plan will still be delivered, but with this information the study team will be able to adjust their treatments to minimize the toxicities of radiation while possibly improving the ability to treat the area where the tumorwas/is. All of the technologies used to deliver this treatment are approved by the Food and Drug Administration for use in children with high-risk abdominal neuroblastoma.

Objectives

• To study the successful delivery of radiation therapy.
• To learn how breathing affects the delivery of the radiation treatment.
• To minimize the toxicities of radiation while possibly improving the ability to treat only the tumor area.
  

Eligibility

• Patient stable on room air
• Age must be greater than or equal to 6 months and less than 18 years of age
  • The effects of irradiation on the developing human fetus at the recommended therapeutic dose are well documented. For this reason and because irradiation is known to be teratogenic, females of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female participant become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Pregnant women are excluded from this study because irradiation is an agent with the potential for teratogenic or abortifacient effects.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis.
• Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Atmaram S. Pai Panandiker, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.