Trial Information

RESPONSE DEPENDENT TREATMENT OF STAGES IA, IIA AND IIIA HODGKIN'S DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD: A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY

OBJECTIVES: I. Modify chemotherapy courses based on initial response to therapy in children
with newly diagnosed stage IA/IIA/IIIA1 Hodgkin's disease. II. Examine the activity of
variable courses of doxorubicin, bleomycin, vincristine, and etoposide (DBVE) followed by
low-dose involved-field irradiation in these patients. III. Monitor the safety and
feasibility of the response-dependent approach and the morbidity and immediate and long-term
toxic effects associated with this regimen. IV. Assess whether limited therapy is adequate
for patients with an early response. V. Evaluate whether the addition of dexrazoxane can
reduce pulmonary toxicity while not significantly reducing the response rate or event-free
survival. VI. Evaluate whether the frequency and magnitude of myocardial injury during
therapy, as measured by elevated serum cardiac troponin-T, is reduced by the addition of
dexrazoxane.

OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to receive doxorubicin, bleomycin, vincristine, etoposide,
and filgrastim with vs. without dexrazoxane. Filgrastim SC begins on days 6-13; no
filgrastim is given on day 14 or 15. Filgrastim will restart 2 days after completing therapy
and continue until count recovery from expected nadir (ANC greater than 1000 cubic meter
after nadir). Courses repeat every 28 days. Those with stable or responding disease after
2-4 courses receive involved-field radiotherapy 5 days per week for 3.5 weeks. Tanner stage
IV/V patients are eligible for randomization based on a front-end institutional agreement
and may receive standard-field radiotherapy 5 days per week for up to 11 weeks at the
investigator's discretion. Patients are followed yearly until relapse, death, or for a
minimum of 10 years.

PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study over 5 years.