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Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma

Phase 2
3 Years
60 Years
Open (Enrolling)
Ewing's Sarcoma

Thank you

Trial Information

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
6 cycles.

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
receive ImmTher.

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.

Inclusion Criteria:

- High risk Ewing's Family of tumors (metastatic disease at diagnosis, humerus, femur
or trunk primary, bulky primary (greater than 8 cm)), or LDH greater or equal to 900
IU/ml prior to biopsy.

- No prior chemotherapy.

- Written informed consent

- Normal cardiac function (ejection fraction greater or equal to 50%).

- Males and non pregnant females.

- Biologic age 3-60 years old.

- Adequate bone marrow function (defined as an absolute peripheral granulocyte count
of>500/mm3, platelet count of >75,000/mm3, and hemoglobin >8g/dl with transfusion if

- Adequate renal function defined as BUN <30mg% and serum creatinine <1.5 x normal for
age or creatinine clearance >70.

- Patients of child bearing potential must agree to use an effective method of

- Normal hepatic function (bilirubin <1.5mg/dl, SGOT or SGPT <3x normal).

Exclusion Criteria: N/A

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

13 Years

Safety Issue:


Principal Investigator

Eugenie S. Kleinerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 1997

Completion Date:

Related Keywords:

  • Ewing's Sarcoma
  • Ewing's Sarcoma
  • Vincristine
  • Doxorubicin
  • Adriamycin
  • Rubex
  • Cyclophosphamide
  • Dexrazoxane
  • Zinecard
  • VACdxr
  • ImmTher
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma



UT MD Anderson Cancer Center Houston, Texas  77030