VACDXR W/ OR W/OUT IMMTHER FOR NEWLY DIAGNOSED HIGH RISK EWINGS SARCOMA

University Of Texas Hlth Sci Ctr Houston, Houston TX

Investigators

Linked publications & trials

Abstract

Patients with Ewing's Sarcoma family of tumors with a large primary, a primary in the humerus, femur or trunk or those with metastatic disease at diagnosis, are at high risk for treatment failure. Recently, a very high-dose short-term VAC regimen was shown to have excellent anti-tumor activity and manageable toxicity in this group of patients. VAC is Vincristine (V), Doxorubicin (A), Cyclophosphamide (C). The investigators will build on this dose-intensive regimen by adding the cardioprotectant Dexrazoxane (dxr) and increasing the dose of A from 75 mg/m2 to 90 mg/m2 per course. In addition, ImmTher, an immune modulator which activates monocyte-mediated tumor cell killing, will be given to 2/3 of the patients following primary chemotherapy, surgery, and/or radiotherapy. ImmTher induced regression of lung and liver metastases in a Phase I study. Since the lung is a common site of metastasis in this disease, the goal is to activate pulmonary macrophages to destroy residual tumor cells. The aims of this randomized Phase II trial are: 1) to determine if dose intensive VACdxr with or without ImmTher can improve the 2-year disease-free survival seen with standard VAC therapy; 2) to evaluate the feasibility and describe the toxicity associated with VACdxr; 3) to evaluate the feasibility and describe the toxicity of administering ImmTher on a weekly basis for one year; 4) to determine which therapy, VACdxr with Immther or VACdxr without ImmTher, is worthy of further evaluation. A maximum of 104 patients will be randomized. Patients will be stratified according to the presence of bony metastases.