Protocol
RAR332: Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy
Diseases
Solid Tumor : Adrenocortical tumors
Description
Participants in this research study have been diagnosed with a rare and aggressive type of cancer in the adrenal gland that is located next to one of the kidneys. This type of cancerous tumor is known as adrenocortical tumor or ACT.
There is no well accepted standard treatment for adrenocortical tumors due to their rare occurrence. Surgery to remove the cancer is the most common treatment. Surgery does not always remove all of the cancer and it can return. This often occurs when the disease has advanced at the time of diagnosis and the surgery to remove the cancer cannot be performed. When the disease has reached this stage, the treatment includes chemotherapy (anticancer drugs).
There are three possible treatment plans in this study. The treatment plans are based on the stage of the disease. Stages are assigned according to how advanced the disease is, the size of the tumor, and whether the disease has spread.
ACT in children are very commonly associated to the presence of a mutation in the p53 gene. This gene is very important for the normal growth and development of all the cells in the body and protects them from damage. Changes in this gene may cause cells to become cancerous and have been linked to adrenocortical tumors. Children that are born with a defective (mutated) gene have an increased risk of developing cancers, and the ACT are very common. In many instances, other family members have the same defective gene. For this reason, participants in this research study will be asked to donate a blood sample before starting treatment. This blood sample will be used to study the p53 gene. This is a voluntary part of the research study. Participants may decide not to participate in this part of the study and still be included in the treatment plan of the study.
Objectives
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To study how effective surgery alone is for participants with early stages of adrenocortical tumors
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To determine if it is better to do a larger surgery than usual and remove more lymph nodes in some participants
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To study how well a specific combination of anticancer drugs work for subjects with more advanced stages of adrenocortical tumors
Eligibility
- Participant was less than 22 years of age at the time of diagnosis with adrenocortical carcinoma
- Participant is able to perform ordinary tasks and daily activities as defined in the study guidelines
- Participant has adequate kidney, liver, lung, and bone marrow function as defined in the study guidelines
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
Catherine Lam, MD, MPH
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-521-9005
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.