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AREN0534


Title

Wilms Tumor - Treatment for Patients with Unilateral Wilms Tumor

Therapeutic Area Wilms Tumor (pediatric)
Principal Investigator Michael J. Kelly, MD
Min Age 0 Years
Max Age 30 Years
Gender Both
Contact Jennifer Truong
617-636-8885
More Information http://clinicaltrials.gov/ct2/show/NCT00945009

Overview

This research study  is for people who have been diagnosed with Wilms tumor. Wilms tumor is a type of cancer that occurs in the cells of the kidney. A doctor called a pathologist looks at the cells that make up the tumor. The diagnosis of Wilms tumor is based on the types of cells seen in the tumor.The overall goal of this study is to find ways to get rid of the tumor cells while saving the largest amount of normal kidney tissue possible. 

Study Details

Inclusion Criteria

  • Prior enrollment on AREN03B2, the Children's Oncology Group (COG) biology study for renal tumors 
  • Diagnosis of Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor 
  • Adequate liver and heart function

Exclusion Criteria

  • Prior chemotherapy or radiation treatment for this disease 
  • Pregnancy

Study Requirements

All subjects will begin treatment with 6 weeks of one of four different chemotherapy regimens. The regimen assignment will be based on  the type of disease and kinds of tumor cells 

Subjects will be evaluated after the completion of the two cycles of drug therapy. The evaluation will include scans and often a biopsy to see if the tumor’s cell characteristics have been changed by the therapy. Based on the findings, subjects may receive more chemotherapy with the same or different regimen or surgery and then more chemotherapy with the same or a different regimen. Some patients with higher stage tumors may also get some radiation therapy. In general, if the tumor cells are all killed and were removed by surgery, a two-drug regimen will be given when chemotherapy continues. If there are active tumor cells in the tumor that is removed, one of the three-drug regimens will be assigned when chemotherapy continues. If the active tumor cells are the aggressive kind that are not responsive to this type of therapy, a four-drug regimen  or a five-drug regimen  will be assigned when chemotherapy continues. 

A growth factor drug called filgrastim may be given to facilitate the recovery of blood counts during treatment. The regimens last from 18 to 43 weeks. After treatment, subjects will have follow-up examinations and medical tests.

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