Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
Patients will be assigned at random (as by the toss of a coin) to receive 1 of 2 treatments.
Arm A: VACdxr will be given over 2 days through a needle in a vein. On day 1, vincristine
will be given over 15 minutes, and doxorubicin will be given over 30 minutes.
Dexrazoxane will be given 30 minutes before doxorubicin; this drug protects the heart from
damage by doxorubicin. Cyclophosphamide will be given once a day on days 1 and 2. This
will make up 1 cycle of VACdxr treatment; the cycle will be repeated every 3 weeks for up to
To prevent some side effects of VACdxr, the drugs Mesna and Neupogen/or Neulasta will also
be given. Mesna helps prevent bladder damage. Neupogen is a growth factor that stimulates
the body to make more white blood cells. Neulasta is a growth factor related to Neupogen.
After cycle 3, surgery may be done to remove any tumor that remains. The principal
investigator will also decide whether radiation treatment should be done. If so, patients
will receive radiation therapy.
Starting 1 month after all treatment is done, patients will receive ImmTher. ImmTher
stimulates the body's white blood cells to attack and kill tumor cells. The drug will be
given through a needle in a vein over 1 hour, every week for 1 year.
Arm B: Patients will be treated the same as patients in Arm A, except that they will not
Patients may have to stay in the hospital during VACdxr treatment and after surgery.
Patients will receive ImmTher in the outpatient clinic.
Before treatment starts, patients will have a complete exam including blood and urine tests
and an EKG and ECHO or MUGA (heart function tests). X-rays and CT, MRI, bone marrow
aspiration, and bone scans will be done. Women will have a pregnancy test.
After each treatment with drugs, after surgery, and after radiation treatment, patients will
have checkups. These will include blood and urine tests and sometimes x-rays.
After cycle 3 of VACdxr, patients will have chest x-ray and x-ray of primary tumor. CT
chest, MRI, bone marrow aspiration and bone scans will be done after 3 cycles as indicated.
These tests will be done to record and measure tumors.
After treatment stops, patients will return for checkups every 3 months for 2 years.
This is an investigational study. ImmTher is an investigational agent. All other study
drugs are approved by the U.S. Food and Drug Administration. As many as 104 patients will
take part in the study; about 95 of these will be treated at M.D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To see if treatment with the drugs, vincristine, doxorubicin, cyclophosphamide and dexrazoxane (VACdxr) given in high doses with or without ImmTher will help patients with Ewing's Sarcoma live longer.
Eugenie S. Kleinerman, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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