Protocol

REN533: Treatment of Newly Diagnosed, Higher Risk, Favorable Histology Wilms Tumor

Diseases

Solid Tumor : Wilms tumor

Description

Phase III study for Stage III/IV Wilms tumor with favorable histology. This means that the cancer cells look almost like normal cells in the kidney when looked under a microscope by a pathologist, but there is residual tumor in the abdomen or metastases (spread) to other sites in the body. There are two treatment questions on this study. For patients with tumor that has spread only to the lungs, we will evaluate how the tumors responded to chemotherapy after 6 weeks. If the lung tumors have resolved, the patient will not receive lung radiation. If the lung tumors have not resolved or if the cancer has spread to other sites, the patient will receive more intensified therapy including lung radiation.

The second treatment question is to determine if patients with specific genetic changes in their tumor have an improved outcome (better survival) when treated with more intensive chemotherapy. Treatment on this study for all participants will last about 6-8 months.

Objectives

• To find out if children and young adults with Wilms tumor that has spread only to their lungs can be treated without having radiation therapy to their lungs. Participants on this study whose lung tumors go away completely after the first six weeks of standard chemotherapy will not get radiation therapy to their lungs.
• To find out if children and young adults with Wilms tumor that has spread only to their lungs and whose lung tumors do not go away after the first six weeks of standard chemotherapy can then be treated by using two additional chemotherapy drugs in addition to radiation therapy to their lungs.
• >To find out if children and young adults with Wilms tumor that has spread to other parts of the body in addition to or instead of to the lungs, can be treated by using two additional chemotherapy drugs along with the standard drugs, and standard radiation therapy to all sites of disease.
• To find out if some genetic information about the tumor cells can help us identify which participants should be treated with five drugs (more intensive chemotherapy) instead of only three drugs in order to have a better response.

Eligibility Criteria, among others, include:

• Participant must be less than 30 years old at the time of initial diagnosis.
• Participant has been enrolled on RENBIO for central pathology review.
• Participant is newly diagnosed Stage IV Wilms tumor with favorable histology or newly diagnosed Stage III Wilms tumor with LOH for 1p and 16q.
• Participant has adequate liver and cardiac functions.
• If participant is of childbearing potential, agrees to use effective contraception.

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

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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.