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Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane With and Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma (NCT00003667)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewing's sarcoma.
  • Drug: cyclophosphamide
    • Drug: dexrazoxane hydrochloride
      • Drug: disaccharide tripeptide glycerol dipalmitoyl
        • Drug: doxorubicin hydrochloride
          • Drug: vincristine sulfate
            • Procedure: surgical procedure
              • Radiation: radiation therapy
                Ages eligible for Study
                3 Years to 60 Years
                Genders eligible for Study
                Accepts Healthy Volunteers
                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 years.

                PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within approximately 5 years.

                2 locations

                United States (2)
                • Memorial Sloan-Kettering Cancer Center
                  Not specified
                  New York, New York, United States, 10021
                • University of Texas - MD Anderson Cancer Center
                  Not specified
                  Houston, Texas, United States, 77030
                31 August, 1998
                23 June, 2013
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