Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma
Patients receive doxorubicin hydrochloride intravenously (IV) and vinblastine IV on day 1 of
weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5;
vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on
day 1 of weeks 3 and 7; and prednisone orally (PO) three times daily every other day for 8
weeks. Two to 3 weeks after all chemotherapy is given, patients not achieving a complete
response undergo radiation therapy to individual nodal sites (tailored fields).
1. To increase the complete response rate of favorable risk patients (excluding all patients
with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by
at least 20% compared to favorable risk patients on HOD 99 after 8 weeks vincristine,
doxorubicin hydrochloride, methotrexate and prednisone (VAMP).
1. To estimate the disease failure rate within the radiation fields.
2. To examine patterns of treatment failure for children treated with low dose tailored
field radiation therapy.
3. To describe acute hematologic and infectious toxicities as they relate to transfusion
requirements, growth factor support, episodes of febrile neutropenia, and
hospitalizations, according to the National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) version 3.0.
4. To compare the survival distributions (event-free and overall) and cumulative incidence
of local failure and toxicities of favorable risk patients treated with 8 weeks of
Stanford V chemotherapy and low-dose tailored-field radiation to those on the favorable
risk group of the HOD 99 study that received VAMP and low-dose involved-field
5. To compare the survival distributions between patients that will not be prescribed
radiotherapy after 8 weeks Stanford V and those patients on HOD 99 that did not receive
radiotherapy after VAMP.
6. To estimate the event-free survival distributions of favorable risk patients treated
with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy
plus low dose tailored field radiation.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients that will not require any radiotherapy by at least 20% more compared to the favorable risk arm in HOD99
A 95% confidence interval of the complete response (CR) rate will be provided.
Monika Metzger, MD, MSc
St. Jude Children's Research Hospital
United States: Institutional Review Board
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Maine Center for Cancer Medicine and Blood Disorders||Scarborough, Maine 04074|
|Packard Children's Hospital, Stanford University||Palo Alto, California 94304|
|Rady Children's Hospital- San Diego||San Diego, California 92123|
|Dana-Farber Harvard Cancer Center||Boston, Massachusetts 02115|