Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study

Trial Information

Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study

OBJECTIVES: I. Determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide,
prednisone and cyclophosphamide (DBVE-PC) with filgrastim (G-CSF) followed by consolidative
radiotherapy in children with advanced stage Hodgkin's disease. II. Tailor therapy based on
rapidity of response in order to minimize cumulative drug dosages. III. Compare the efficacy
of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without
compromising response.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on
days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and
prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course
is 21 days in length. Patients assigned to arm I receive only these drugs. Patients assigned
to arm II receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm I.
Patients who exhibit a complete remission (CR) or provisional CR then receive radiotherapy
to the regional field 5 days a week for 2.8 weeks. If the disease is not responsive, 2 more
courses of chemotherapy are given. Patients whose disease remains nonresponsive or
progresses go off the study. Radiotherapy may follow for others. Patients are followed every
3 months for the first year, every 4 months for the second year, every 6 months for the
third year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 277 patients will be accrued for this study within 3 years.