Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Biological Therapy in Treating Patients With High-Risk Ewing's Sarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 3 to 60 NCI, Pharmaceutical / Industry MSKCC-98074 ENDOREX-MSKCC-98074, MDA-ID-97198, NCI-G98-1487, NCT00003667

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.

Entry 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)

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Paul Meyers, MD, Protocol chair		Ph: 212-639-5952; 800-525-2225 Email: meyersp@mskcc.org

Registry Information
Official Title		Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane With and Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
Trial Start Date		1998-09-08
Registered in ClinicalTrials.gov		NCT00003667
Date Submitted to PDQ		1998-11-20
Information Last Verified		2007-05-31