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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

Phase 2
3 Years
60 Years
Not Enrolling

Thank you

Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven high risk Ewing's family of tumors: Ewing's
sarcoma of bone Extraosseous Ewing's sarcoma Peripheral neuroepithelioma Must have one of
the following characteristics: Metastatic disease at diagnosis Primary tumor of the
humerus, femur, or trunk Bulky (greater than 8 cm) tumor Elevated LDH prior to biopsy (at
least 900 IU/mL)

PATIENT CHARACTERISTICS: Age: 3 to 60 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 500/mm3 Platelet count at least
75,000/mm3 Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: Bilirubin no greater
than 1.5 mg/dL SGOT or SGPT no greater than 3 times normal Renal: BUN less than 30 mg/dL
Creatinine no greater than 1.5 times normal for age OR Creatinine clearance at least 70
mL/min Cardiovascular: Ejection fraction at least 50% OR Fractional shortening at least
29% Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Paul A. Meyers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

August 2000

Related Keywords:

  • Sarcoma
  • nonmetastatic childhood soft tissue sarcoma
  • metastatic childhood soft tissue sarcoma
  • extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Neuroectodermal Tumors, Primitive
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009