IRB Number:

06-002802

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The standard treatment for Hodgkin disease is chemotherapy and radiation therapy (high-dose x-rays). Most patients are cured of their Hodgkin disease, but some people have late effects from the treatment later in life. Late effects can include problems with growth, organ function, and sometimes a second kind of cancer. Late effects may be caused by either chemotherapy or radiation. Researchers believe that if some people can be treated with less treatment or with surgery alone, then these people might have fewer late effects.
This study is being done to:
- See if "late effects" (side effects that show up later in life from the treatment) can be lowered or prevented by using less chemotherapy and radiation.
- Find out if using less chemotherapy and radiation to treat LPHD will still show high cure rates or if cure rates will be lower than with standard treatment.

Who is Eligible to Participate in the Study?

- Ages birth through 21 years
- Newly-diagnosed with previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD)

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

What is Involved With this Study?

- Physical exams
- Blood tests
- Urine tests
- Hormone function tests
- Kidney function tests
- CT scans (a scan that takes a picture of the inside of the body).
- PET (a scan that takes pictures of body tissue to see if there is any cancer)
- Pregnancy test (for females of childbearing age)
- Central line placement, before treatment with AV-PC starts. A central line is a special type of tube put into a large vein in the chest by a doctor during a short operation. The central line is used to give chemotherapy drugs and to take out small amounts of blood for testing during treatment.
- Medications: Patients who take part in this study will either be observed (no treatment) or receive treatment with Adriamycin/Doxorubicin (A) through a vein, Vincristine (V) through a vein, Prednisone (P) in pill form, Cyclophosphamide (C) through a vein, or AV-PC through a vein.

How long will the Study run?

Patients who get chemotherapy and radiation will receive treatment in the study for 3 to 4 months, depending on which treatment they get. Many things affect how long patients will be in the study, such as response to treatment and unplanned delays and illness, which can change the length of time treatment will take. We would also like to keep on finding out about the patients' health for about 10 years after the study closes to new patients.

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

Study Activation/Registration Date: 11/13/2006

IRB Review and Approval Date: 09/07/2006

Study Type: Treatment

Projected Accrual: The plan is to have up to 150 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: Shakila Khan, 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: 05/23/2008