Study on Chemotherapy With or Without Radiation for Young Patients With Favorable-Risk Hodgkin Lymphoma
Sponsor: St. Jude Children's Research Hospital
ClinicalTrials ID:NCT00846742
This clinical trial is exploring how well a combination of chemotherapy drugs, with or without radiation therapy, works in treating young patients with favorable-risk Hodgkin lymphoma. The study aims to find out if adding radiation therapy to chemotherapy can improve treatment outcomes.
Patient Parameters
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Program Overview
This study is testing whether using a combination of chemotherapy drugs, with or without radiation therapy, is effective in treating young patients with favorable-risk Hodgkin lymphoma. Chemotherapy drugs like doxorubicin, vinblastine, and others work by killing cancer cells or stopping them from growing. Radiation therapy uses high-energy x-rays to target and kill cancer cells, especially for patients who still have cancer after chemotherapy. The goal is to see if combining these treatments can kill more cancer cells and help preserve the affected area of the body.
Description
In this study, patients will receive a series of chemotherapy drugs over 8 weeks. These drugs include doxorubicin and vinblastine given through an IV on specific weeks, along with other drugs like mechlorethamine, vincristine, bleomycin, etoposide, and prednisone taken orally. After completing chemotherapy, if the cancer is not completely gone, patients may receive radiation therapy targeted to specific areas where cancer remains.
The main goal is to increase the number of patients who have no signs of cancer after 8 weeks of treatment compared to previous studies. The study will also look at how often cancer returns in areas treated with radiation, the side effects related to blood and infections, and compare survival rates and treatment outcomes with previous studies.
The study will also compare outcomes between patients who receive radiation after chemotherapy and those who do not, to see if radiation provides additional benefits.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Hodgkin lymphoma that has not been treated before.
- Must be 21 years old or younger.
- Cancer stage must be IA or IIA with:
- Non-bulky disease in the chest area.
- Less than 3 lymph node areas affected on the same side of the diaphragm.
- No 'E' lesions (cancer outside the lymph nodes).
- Female patients who have started menstruating must have a negative pregnancy test and agree to use effective birth control.
- Must provide signed informed consent.
- If the disease is found to have intermediate risk features upon re-evaluation, the patient will be removed from the study.
Exclusion Criteria
- Intermediate or high-risk disease, defined as:
- Stage IB, III, or IV.
- Stage IA/IIA with 'E' lesions, 3 or more lymph node areas affected, or bulky disease in the chest.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Packard Children's Hospital, Stanford University | 94304 | Palo Alto | California |
| Rady Children's Hospital- San Diego | 92123 | San Diego | California |
| Children's Hospital of Illinois at OSF St. Francis Medical Center | 61637 | Peoria | Illinois |
| Maine Children's Cancer Program (MCCP) | 04074 | Scarborough | Maine |
| Dana-Farber Harvard Cancer Center | 02115 | Boston | Massachusetts |
| St. Jude Children's Research Hospital | 38105 | Memphis | Tennessee |
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