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ARAR0332 Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy

Purpose of study:

This type of tumor is called an adrenocortical tumor (ACT).

Treating ACT requires that the tumor be totally removed. Because of this, surgery is likely the most important part of standard treatment for ACT. The scale of the surgery will depend on the stage of the disease. Surgery often requires that some surrounding tissues and even parts of other organs be removed too.

ACT may return or spread to other parts of the body even after surgery. We think that some disease may remain in the lymph nodes nearby after the tumor has been removed. It is common for patients with early stages of ACT to have some of the lymph nodes near the tumor removed. We would like to remove all of the lymph nodes nearby for those subjects with an early stage of ACT who have a large tumor. We want to find out if this larger surgery than usual
will offer a better cure rate.

If ACT is at an early stage and the tumor can be totally removed by surgery, then no other treatment is needed. However, for people with advanced disease, chemotherapy has to be used.
The drug mitotane is effective against ACT but at high doses it also causes many side effects. Most of our current information about the effects of this drug (both good and bad) has come from treatment on adults rather than children. Giving mitotane at lower doses in children may avoid some of the side effects and still help fight the tumor. When mitotane is given at a lower dose it needs to be taken for a longer period of time. It may have to be taken for several
months for it to work.

Combinations of different chemotherapy drugs are used to treat cancers. Recent studies have shown that adding the drug mitotane to a combination of the drugs cisplatin, etoposide and doxorubicin can be effective. By giving mitotane with other drugs, instead of alone, we may improve the treatment for ACT.

The main goals of this study are:
1) To see how effective surgery alone is for subjects with early stages of ACT (Treatment Groups 1 and 2).
2) To find out if it is better to do a larger surgery than usual (and remove more lymph
nodes) in some subjects (Treatment Group 2).
3) To find out how well a combination of mitotane with cisplatin, etoposide and
doxorubicin works for subjects with more advanced stages of ACT (Treatment Group 3).

The other goals of this study are:
A) We want to make sure that the benefits of larger surgery is better for some early stage of disease. We want to make sure that the benefits outweigh the added risks;
B) To find out how common it is for lymph nodes to be affected by ACT;
C) To find out what the risks (toxicities) of mitotane are when it iscombined with certain other chemotherapy drugs.?

Who can participate:

Newly diagnosed patients with histological diagnosis of adrenocortical carcinoma. Patients must be less than 22 years of age at the time of diagnosis.

Additional screening for eligibility will be required.

What will happen during the study:

Treatment

You will get chemotherapy, and if there is a good response you may have another surgery. Surgery will include removing the tumor and also all of the lymph nodes nearby. If the cancer has spread, then any other tumors in other parts of the body will also be removed, when possible.
The chemotherapy will last about 8 months (32 weeks). If you also have surgery then the total treatment time may be longer.

If you choose not to take part in this study you will likely still get the same chemotherapy drugs and similar surgery.

Chemotherapy Schedule
You will get Induction therapy over a period of 6 to 12 weeks in order to shrink the tumor. You might then have another surgery. If the tumor shows a good response to Induction therapy, then you will go on to Continuation therapy. Continuation therapy will last about 20 to 26 weeks.Induction therapy is the use of chemotherapy to reduce/get rid of the cancer. If the cancer goes away then the disease will be “in remission”.Continuation therapy is treatment intended to make the cancer stay in remission.

Induction Therapy
Induction therapy consists of 2 to 4 cycles of chemotherapy with the drugs mitotane, cisplatin, etoposide and doxorubicin. Each cycle will last 21 days. After 2 cycles you will be evaluated and if surgery is right for you it will be scheduled as soon as possible.

Continuation Therapy
You will have 4 to 6 more cycles of chemotherapy with the same drugs used during Induction. The drugs will be given in the same way. Once you have finished a total of 8 cycles of chemotherapy, you will continue to get mitotane alone every day, for up to 8 more weeks. The total time that you will get mitotane will be 8 months.?

Who to contact:

PI: Mark Ranalli, MD
614-722-3563
Mark.Ranalli@nationwidechildrens.org
 

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000