IRB Number:

07-003837

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Patients are being asked to take part in this study because they have a Wilms tumor in which the cancer cells look almost like normal cells in the kidney (this is called favorable histology).
There is, however, some risk that the cancer will return after treatment.

It is common to enroll children and adolescents with cancer in a clinical trial that seeks to
improve cancer treatment over time. Clinical trials include only people who choose to take
part. Patients have a choice between a standard treatment for Wilms tumor and this clinical trial.
The usual treatment for people with these tumors is to have surgery to remove as much tumor as possible, then anti-cancer drug therapy (chemotherapy), and some therapy with high energy X-ray (radiation therapy).

Chemotherapy and radiation have side effects and late effects, so study doctors are trying to find out the amount of treatment to give patients that will treat their cancer and at the same time have less of these effects. Late effects are health problems that happen to patients later in life because of the drugs or radiation used to treat their cancer. Late effects may include health problems such as poor growth, inability to have children, impaired organ function (such as problems with breathing, poor heart function or heart failure) or the development of a second type of cancer.

The overall goal of this study is to find out if:
Patients with Wilms tumor that has spread only to their lungs can be treated without having radiation therapy to their lungs. Patients whose lung tumors go away completely after the first six weeks of standard chemotherapy will not have to have radiation therapy

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 for Wilms tumor can be treated by using two additional chemotherapy drugs, plus radiation therapy

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 radiation therapy

Some genetic information about the tumor cells can help the researchers put patients in the experimental treatment group.

Who is Eligible to Participate in the Study?

-Under age 30 at time of diagnosis
-Diagnosed with Stage 3 or 4 Wilms tumor in which the cancer cells look almost like normal cells in the kidney (this is called favorable histology)
-No prior tumor-directed chemotherapy or radiotherapy

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

All patients who enroll on this study will start treatment with a common therapy for high risk Wilms tumor patients called Regimen DD4A (Vincristine, Dactinomycin, Doxorubicin). After about six weeks of therapy, patients will have scans done to see how their tumors have reacted to the therapy.

Patients who only had tumors that spread to the lung(s), and whose lung tumors disappear after six weeks of standard therapy, will continue with the standard therapy (Regimen DD4A). However, these patients will not get any radiation therapy. This is experimental therapy, since these patients would commonly be given radiation therapy.

Patients who had tumors that spread to other places (or to the lungs and other places), and those with only lung tumors that did not disappear after six weeks of standard therapy, will get a new experimental treatment called Regimen M (Cyclophosphamide, Etoposide, Vincristine,
Dactinomycin, Doxorubicin). Regimen M has two extra common chemotherapy drugs in it; patients would not get these drugs on standard treatment. Patients on Regimen M will also get standard radiation therapy.


Treatment Plan
The treatment on this clinical trial takes about 6-8 months. This will depend on whether the patient gets Regimen DD4A therapy or Regimen M therapy.

Standard tests and procedures
The following tests and procedures are part of regular cancer care and may be done even if the patient does not join the study.
- Frequent labs to monitor blood counts and blood chemistries
- Urine tests to measure how the kidneys are functioning
- Pregnancy test for females of childbearing age before treatment begins
- X-rays and scans to monitor the subject's response to treatment.
- Tests to monitor heart functioning

Standard follow-up schedule:
-Medical History every three months for two years, then every six months for the next two years and then every year for six years
-Physical Exam every three months for two years, then every six months for the next two years and then every year for six years
-Blood tests every six months for two years, then every year for eight years
-Urinalysis every six months for two years, then every year for eight years
-Total protein/albumin every six months for two years, then every year for eight years
-CT chest end of Therapy and then every three months for two years
-Chest x-ray starting 24 months after end of therapy: every six months for two years, then once a year as long as the doctor thinks it is needed
-CT or MRI abdomen/pelvis end of Therapy and every three months for two years, then switch to abdominal ultrasound
-Abdominal ultrasound starting 24 months after end of therapy: every six months for two years, then once a year as long as the doctor thinks it is needed
-Echo/EKG end of therapy and then as often as the doctor thinks it is needed

Research study tests and procedures
Patients will need these tests and procedures that are part of regular cancer care, but they are being done more often because the patient is in this study.
- Blood tests
- Scans and X-rays to find out where the tumor is located in the body
- Urinalysis
- Tests to find out how the patient's heart is working

How long will the Study run?

Patients in this clinical trial are expected to receive treatment on this study for 6 to 8 months.
After treatment, patients will have follow-up examinations and medical tests. The standard schedule for patient follow-up is listed above. In addition, the researchers would like to continue to collect some medical information about how the patient is doing for about ten years after the study closes to patient enrollment. Keeping in touch with the patient and checking on how their health is every year for a while after the study closes helps the research staff understand the long-term effects of the study.

Sponsor(s): Children's Oncology Group (COG)

Study Activation/Registration Date: 07/24/2007

IRB Review and Approval Date: 07/17/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 295 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Vilmarie Rodriguez, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/12/2008