Protocol

REN534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally- Predisposed Unilateral Wilms Tumor

Diseases

Solid Tumor : Wilms tumor

Description

Wilms tumor is a type of cancer that occurs in the cells of the kidney. Children with Wilms tumor in both of their kidneys (bilateral) account for 5-7% of all patients with Wilms tumor. Certain patients, with syndromes associated with Wilms tumor development, may have an increased risk for bilateral tumors. The diagnosis of Wilms tumor is based on the types of cells seen in the tumor. Wilms tumor is best treated when it is found early, before it has spread to other areas of the body. The most common way to treat bilateral Wilms tumor is to give two or three common anti-cancer drugs (chemotherapy with vincristine, dactinomycin, and sometimes doxorubicin) to shrink the tumors and then to do surgery to remove the tumor tissue. In some cases, an entire kidney and part of the other kidney are removed. Sometimes radiation therapy (treatment with high energy X-rays) is also done.

Objectives

• For participants with bilateral Wilms tumor, one goal is to  find out if giving three chemotherapy drugs before surgery will help get rid of the tumor cells while saving the largest amount of normal kidney tissue and if the tumors shrink to allow surgery by 12 weeks after starting treatment.
• For patients who have many lesions in both kidneys that might become Wilms tumor (called diffuse hyperplastic perilobar nephrogenic rests or DHPLNR), this study will investigate if the development of Wilms tumor can be prevented by giving the patient chemotherapy.
• In patients who only have Wilms tumor in one kidney but have a risk of developing Wilms tumor in the other kidney due to medical conditions such as Beckwith-Wiedemann syndrome, aniridia, or hemihypertrophy, this study investigates if giving chemotherapy before surgery would allow the tumor to be removed while saving the rest of the kidney.

Eligibility

• Patient must be less than or equal to 30 years old at the time of initial diagnosis.
• Patient must have one of the following diagnoses:
  • Unilateral Wilms tumor and a medical condition that increases the risk of developing Wilms tumor in the other kidney
  • Multicentric Wilms tumor
  • Diffuse hyperplastic perilobar nephroblastomatosis
  • Wilms tumor in a patient with only one kidney
• Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study
• Patients must meet requirements for adequate heart, liver, and kidney function
• Female patients of childbearing age must have a negative pregnancy test and female patients who are lactating must agree to stop breast-feeding.

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

Rachel Brennan, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
Fax: 901-595-4011

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.