Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane With and Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
OBJECTIVES: I. Compare the effects of dose intensive regimens of vincristine, doxorubicin,
cyclophosphamide, and dexrazoxane with or without ImmTher (a muramyl dipeptide liposome) on
the 2 year disease-free survival of patients with newly diagnosed high risk Ewing's sarcoma.
II. Evaluate the feasibility and determine the toxicity of administering weekly ImmTher for
1 year to these patients. III. Determine which therapy is worthy of further evaluation.
OUTLINE: This is a randomized study. Patients are stratified according to the presence of
bony metastases at diagnosis. Patients are randomized to one of two treatment arms. All
patients receive dexrazoxane IV followed 30 minutes later by doxorubicin IV over 30 minutes
on day 1, vincristine IV on day 1, and cyclophosphamide IV over 6 hours on days 1 and 2.
Treatment is repeated every 3 weeks for 3-6 courses in the absence of disease progression or
unacceptable toxicity. Patients are evaluated after course 3 and undergo surgery and/or
radiation therapy. The next 3 courses of chemotherapy are administered after recovery from
surgery/radiation therapy. Within 1 month after completion of all chemotherapy courses,
patients randomized to arm I receive ImmTher IV over 60 minutes weekly for 1 year. Patients
randomized to arm II receive no further therapy. Patients are followed every 6 weeks for 2
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within
approximately 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Paul A. Meyers, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|