Treatment for very low and standard risk favorable histology Wilms tumor

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrials.gov/ct2/show/NCT00352534?term=Treatment+for+Very+Low+and+Standard+Risk+Favorable+Histology+Wilms+Tumor&rank=1

2. Intervention

   Doxorubicin hydrochloride

3. Intervention

   Vincristine sulfate

4. Intervention

   Radiation therapy

5. Additional Topic(s)

   Antineoplastic combined chemotherapy protocols

6. Additional Topic(s)

   Radiotherapy

7. Resource Description

   The overall goals of this research study are: - to find out if children less than 2 years old with a small Stage I Wilms tumor can be safely treated with surgery alone followed by careful observation. - to find out if some children with a higher risk of having their tumor return (Stage I or II Wilms tumor with the LOH change) will benefit from the addition of a chemotherapy agent called doxorubicin. Doxorubicin will be added to the current standard treatment regimen of two drugs called vincristine and actinomycin. - to find out if there are things about the Wilms tumor cells that might tell us why standard treatment does not get rid of the tumor for all III Wilms tumor patients without the LOH change. Note that children with stage III Wilms tumor with the LOH change will be offered participation in a different study called AREN0533. Also, treatment information from this study will be linked to the tumor samples collected as part of the AREN03B2 study. Researchers hope that they will be able to tell if any other biological or genetic factors can help predict the best treatment for patients with these renal tumors.

8. Contact

   Berenberg, Jeffrey

9. PI

   Wilkinson, Robert, M.D.

10. Topic

    nephroblastoma

11. Study Population

    Patients must be less than 30 years of age at diagnosis with newly diagnosed stage I – III Wilms Tumor that were previously enrolled on study AREN03B2.

12. Website(s)

    http://www.curesearch.org/ArticleView2.aspx?id=9108&l=8673

13. Funded by

    Children's Oncology Group

14. Phase

    Phase 3 clinical trial

15. Performed by

    Clinical Protocol & Data Management Shared Resource