Risk-Adapted Therapy for Pediatric Hodgkin's Disease
This study will evaluate the following objectives:
1. To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with
favorable risk Hodgkin's disease who achieve a complete response after 2 cycles of VAMP
2. To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients
with favorable risk Hodgkin's disease who achieve a partial response after 2 cycles of
3. To evaluate the efficacy of 2 alternating cycles of VAMP/COP chemotherapy (total 4
cycles of chemotherapy) plus low-dose, involved-field RT in children with intermediate
risk Hodgkin's disease.
4. To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose,
involved-field RT in children with unfavorable risk Hodgkin's disease.
1. To evaluate patient quality of life during and after treatment from the patient and
2. To compare patient and parental ratings of treatment-related symptoms and patient
physical, psychological, social and cognitive functioning before the first treatment
(T1 - baseline); after Cycle 2 or after 8 weeks of Stanford V (T2 - Evaluate Response);
after cycle 4 or after 12 weeks of Stanford V and before or on the first day of
radiation (as applicable) (T3); at the conclusion of radiation or within a few days
following the end of radiation (as applicable) (T4); and at 3 to 6 months after
completion of therapy follow-up evaluation (T5).
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free Survival Probability by Risk Group
Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.
Median 6.4 year follow-up
Monika Metzger, MD
St. Jude Children's Research Hospital
United States: Institutional Review Board
|Stanford University||Stanford, California 94305|
|Maine Children's Cancer Program||Scarborough, Maine 04074-9308|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|