Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Hodgkin Lymphoma
NCT ID: NCT00846742 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-273

 

This phase II trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride, cyclophosphamide, vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells for those patients that still had residual cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Alison Friedmann, MD, Massachusetts General Hospital

Site-responsible Investigators:
Amy Billett, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed, previously untreated Hodgkin lymphoma. - Age: Participants must be 21 years of age or younger - Stage must be classified as one of the following: Ann Arbor stage IA or IIA with: - Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR) - < 3 nodal regions involved on the same side of the diaphragm - No "E" lesion - Female patients who are post-menarchal must have a negative pregnancy test. Patients of reproductive potential must agree to use an effective contraceptive method. - Signed informed consent - If re-evaluation of a patient's disease shows intermediate risk features, the patient will be removed from the HOD08 study and consented to the HOD05 study. Exclusion Criteria: - Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with "E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy
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