drugset
drugset / Trial / NCT00038142

Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients

NCT00038142 ↗

Phase 2 Terminated 46 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Objectives: 1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM 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 ImmTherTM on a weekly basis for 50- 52 weeks. 4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.

Timeline

Start
1997-11
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject disaccharide tripeptide glycerol dipalmitoyl Small molecule 900 ug/m2 Intravenous
Background Cyclophosphamide Other / unclassified 2 g Intravenous
Background Dexrazoxane Small molecule 900 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 90 mg/m2 Intravenous
Background Vincristine Small molecule 2 mg/m2 Intravenous

Indications

Ewing sarcoma