Clinical Trials
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors
IRB-HSR# 14379
Service:
Cancer (Children)
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Category: Cancer (Oncology), Pediatrics
Adult Enrollment: Yes
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Minor Enrollment: Yes
Primary Investigator: Kimberly Dunsmore, M.D.
Contact Information
Contact: Candace Hudspeth
Phone: 434.982.1091
E-mail: ckh3k@virginia.edu
Clinical Trial Description
UVA Health System, Department of Pediatrics seeks: children, adolescents, women and men with newly diagnosed Stage IV and newly diagnosed Stage III with LOH for 1p and 16 q Wilms' tumor with favorable histology (in which the cancer cells look almost like normal cells in the kidney) for research study. To be eligible, patients must be less than 30 years of age at the time of diagnosis.
The overall goals of the study are to find out if: (a) patients with Wilms' tumor that has spread only to their lungs can be treated without having radiation therapy to their lungs if they have a good response to initial chemotherapy, (b) patients with Wilms' tumor that has spread only to their lungs whose lung tumors do not go away after the first six weeks of standard chemotherapy will receive benefit from receiving two additional chemotherapy drugs, plus radiation therapy to their lungs, (c) patients who have Wilms' tumor that has spread to other parts of the body in addition to or instead of in 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, and (d) some genetic information about the tumor cells can help us put patients in the experimental treatment group.
The study involves the following tests and procedures which are standard of care: blood draws (which test for things such as blood counts and kidney and liver function), physical exams, urinalyses, echocardiogram, ECG, CT/MRI scans, and taking FDA approved chemotherapy agents. Depending on your treatment plan, you may have radiation therapy and surgery. Patients are expected to receive treatment on this study for 6-8 months depending on which treatment regimen is received. The length of each visit will be comparable to the length of the visits for standard of care treatment; however, there are more visits required for the investigational chemotherapy regimen which includes two additional chemotherapy drugs. For patients who do not receive radiation therapy, there will be fewer visits needed than if receiving standard therapy. Data will be collected on patients for 10 years after the study closes to new patient enrollment.
You and/or your insurance will be billed for all study related medication, tests, treatment, and procedures.
Compensation
No compensation is provided for this study.
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