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Doxorubicin |
Adriamycin; Rubex |
Clinical Trial: Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
This study is currently recruiting patients.
Purpose
The goal of this study is to see if treatment with vincristine, doxorubicin, cyclophosphamide and dexrazoxane (VACdxr) given in high doses with or without ImmTher will help patients with Ewing's Sarcoma live longer. The safety of these treatments will also be studied.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Ewing's Sarcoma | Drug: Vincristine Drug: Doxorubicin Drug: Cyclophosphamide Drug: Dexrazoxane | Phase II |
MedlinePlus related topics: Bone Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Safety/Efficacy Study
Expected Total Enrollment: 104
Study start: November 1997
Last follow-up: November 2004
ImmTher is an investigational agent which stimulates the body's white blood cells to attack and kill tumor cells. Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane are drugs approved by the U.S. Food and Drug Administration.
Eligibility
Ages Eligible for Study: 3 Years - 60 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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.
- Normal cardiac function (ejection fraction greater or equal to 50%).
- Males and non pregnant females.
- Biologic age 3-60 years old.
Location and Contact Information
Texas
University of Texas M.D. Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Mary Ann V. Gianan, B.S.N. 713-794-4967 mgianan@mdanderson.org
Eugenie S. Kleinerman, M.D., Principal Investigator
More Information
Record last reviewed: January 2005
Last Updated: February 1, 2005
Record first received: May 29, 2002
ClinicalTrials.gov Identifier: NCT00038142
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Adriamycin (Drug Digest)
- Doxorubicin (Drug Digest)
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