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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Ewing's Sarcoma
Intervention	Drug: Vincristine Drug: Doxorubicin Drug: Cyclophosphamide Drug: Dexrazoxane Biological: ImmTher
Phase	Phase 2
Sponsor	M.D. Anderson Cancer Center
Responsible Party	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier	NCT00038142
First Received	May 29, 2002
Last Updated	May 6, 2013
Last verified	May 2013

Tracking Information[ + expand ][ + ]

First Received Date	May 29, 2002
Last Updated Date	May 6, 2013
Start Date	November 1997
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	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. [Time Frame: 13 Years] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients
Official Title	Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
Brief 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.
Detailed Description	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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Ewing's Sarcoma
Intervention	Drug: Vincristine 2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6. Drug: Doxorubicin 90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6. Other Names: Adriamycin Rubex Drug: Cyclophosphamide 2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6. Other Names: Cytoxan Neosar Drug: Dexrazoxane 900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6. Other Names: DXR Zinecard Biological: ImmTher 900 mcg/m^2 IV over 1 hour every week x 50-52 weeks.
Study Arm (s)	Experimental: Arm A: VACdxr With ImmTher Vincristine 2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6. Doxorubicin 90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6. Cyclophosphamide 2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6. Dexrazoxane 900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6. ImmTher 900 mcg/m^2 IV over 1 hour every week x 50-52 weeks. Active Comparator: Arm B: VACdxr Vincristine 2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6. Doxorubicin 90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6. Cyclophosphamide 2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6. Dexrazoxane 900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	104
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	November 2014
Eligibility Criteria	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 required). - 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 contraception. - Normal hepatic function (bilirubin <1.5mg/dl, SGOT or SGPT <3x normal). Exclusion Criteria: N/A
Gender	Both
Ages	3 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00038142
Other Study ID Numbers	ID97-198
Has Data Monitoring Committee	Yes
Information Provided By	M.D. Anderson Cancer Center
Study Sponsor	M.D. Anderson Cancer Center
Collaborators	Not Provided
Investigators	Principal Investigator: Eugenie S. Kleinerman, MD M.D. Anderson Cancer Center
Verification Date	May 2013

Locations[ + expand ][ + ]