Ewing's Sarcoma Clinical Trial
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
Verified date | January 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 46 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 60 Years |
Eligibility |
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 blood urea nitrogen (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, serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) <3x normal). Exclusion Criteria: N/A |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year Disease-free Survival (DFS): Effect of Treatment With Combination Drugs in VACdxr Given in High Doses With or Without ImmTher to Help Participants With Ewing's Sarcoma Live Longer | DFS defined as survival of participants to two years post study entry without relapse. | 2 years |
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