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Trial record 2 of 4 for:    "Extraskeletal Ewing Sarcoma" | "Vincristine"

Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma

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ClinicalTrials.gov Identifier: NCT00516295
Recruitment Status : Completed
First Posted : August 15, 2007
Results First Posted : September 2, 2014
Last Update Posted : September 2, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ewing Sarcoma of Bone
Extraosseous Ewing Sarcoma
Peripheral Primitive Neuroectodermal Tumor
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Interventions Drug: topotecan hydrochloride
Drug: vincristine sulfate
Drug: cyclophosphamide
Biological: bevacizumab
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (CTC)
Hide Arm/Group Description

Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.

topotecan hydrochloride: Given IV

vincristine sulfate: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I. Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.
Period Title: Overall Study
Started 7 0 0
Completed 4 0 0
Not Completed 3 0 0
Reason Not Completed
Lack of Efficacy             2             0             0
Ineligible             1             0             0
Arm/Group Title Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (VTC) Total
Hide Arm/Group Description

Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.

topotecan hydrochloride: Given IV

vincristine sulfate: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I. Total of all reporting groups
Overall Number of Baseline Participants 7 0 0 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 0 participants 0 participants 7 participants
15
(12 to 20)
15
(12 to 20)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 0 participants 7 participants
Female 2 2
Male 5 5
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 0 participants 7 participants
American Indian or Alaska Native 0 0
Asian 0 0
Native Hawaiian or Other Pacific Islander 0 0
Black or African American 0 0
White 6 6
More than one race 0 0
Unknown or Not Reported 1 1
Ethnicity (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 0 participants 7 participants
Hispanic or Latino 2 2
Not Hispanic or Latino 5 5
Unknown or Not Reported 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 0 participants 0 participants 7 participants
7 7
1.Primary Outcome
Title The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient.
Hide Description Limiting toxicity defined as Any Grade IV hematological toxicities lasting longer than 7 days, myelosuppression causing delays > 14 days in delivery of therapy, > Grade 3 thromboembolic events, > Grade 3 bleeding events, > Grade 2 hypertension, > Grade 2 proteinuria.
Time Frame First 2 courses (42 days) of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
Arm/Group Title Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (VTC)
Hide Arm/Group Description:

Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.

topotecan hydrochloride: Given IV

vincristine sulfate: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
Overall Number of Participants Analyzed 6 0 0
Measure Type: Number
Unit of Measure: number of toxicities
0
2.Primary Outcome
Title Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab
Hide Description Time from enrollment to disease progression, death, second malignant neoplasm, or last patient follow-up whichever occurs first. Patients who experience disease progression, death or second malignant neoplasm will be considered to have experienced an event; otherwise the patient will be considered censored at last follow-up.
Time Frame Maximum of 5 years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
Arm/Group Title Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (VTC)
Hide Arm/Group Description:

Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.

topotecan hydrochloride: Given IV

vincristine sulfate: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
Overall Number of Participants Analyzed 6 0 0
Median (95% Confidence Interval)
Unit of Measure: days of event free survival
442 [1] 
(42 to NA)
[1]
There is no numerical limit available because the limit is infinity.
Time Frame [Not Specified]
Adverse Event Reporting Description Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
 
Arm/Group Title Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (VTC)
Hide Arm/Group Description

Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.

topotecan hydrochloride: Given IV

vincristine sulfate: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I. Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
All-Cause Mortality
Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (VTC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (VTC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      0/0      0/0    
Blood and lymphatic system disorders       
Febrile neutropenia  4/6 (66.67%)  0/0  0 0/0 
Gastrointestinal disorders       
Esophageal stenosis  1/6 (16.67%)  0/0  0 0/0 
Vomiting  1/6 (16.67%)  0/0  0 0/0 
Infections and infestations       
Infections and infestations - Other, specify  4/6 (66.67%)  0/0  0 0/0 
Injury, poisoning and procedural complications       
Burn  1/6 (16.67%)  0/0  0 0/0 
Investigations       
Platelet count decreased  1/6 (16.67%)  0/0  0 0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Feasibility Assessment of VTCB) Arm II (VTCB) Arm III (VTC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      0/0      0/0    
Blood and lymphatic system disorders       
Anemia  6/6 (100.00%)  0/0  0/0 
Febrile neutropenia  1/6 (16.67%)  0/0  0/0 
Ear and labyrinth disorders       
Middle ear inflammation  1/6 (16.67%)  0/0  0/0 
Gastrointestinal disorders       
Abdominal pain  1/6 (16.67%)  0/0  0/0 
Gastritis  1/6 (16.67%)  0/0  0/0 
Mucositis oral  2/6 (33.33%)  0/0  0/0 
Nausea  1/6 (16.67%)  0/0  0/0 
Oral hemorrhage  1/6 (16.67%)  0/0  0/0 
Immune system disorders       
Allergic reaction  1/6 (16.67%)  0/0  0/0 
Infections and infestations       
Catheter related infection  1/6 (16.67%)  0/0  0/0 
Esophageal infection  1/6 (16.67%)  0/0  0/0 
Infections and infestations - Other, specify  2/6 (33.33%)  0/0  0/0 
Upper respiratory infection  1/6 (16.67%)  0/0  0/0 
Investigations       
Alanine aminotransferase increased  1/6 (16.67%)  0/0  0/0 
Aspartate aminotransferase increased  1/6 (16.67%)  0/0  0/0 
Creatinine increased  1/6 (16.67%)  0/0  0/0 
Lymphocyte count decreased  2/6 (33.33%)  0/0  0/0 
Neutrophil count decreased  4/6 (66.67%)  0/0  0/0 
Platelet count decreased  4/6 (66.67%)  0/0  0/0 
White blood cell decreased  3/6 (50.00%)  0/0  0/0 
Metabolism and nutrition disorders       
Anorexia  2/6 (33.33%)  0/0  0/0 
Hyperkalemia  1/6 (16.67%)  0/0  0/0 
Hypoalbuminemia  1/6 (16.67%)  0/0  0/0 
Musculoskeletal and connective tissue disorders       
Arthralgia  1/6 (16.67%)  0/0  0/0 
Back pain  1/6 (16.67%)  0/0  0/0 
Bone pain  1/6 (16.67%)  0/0  0/0 
Nervous system disorders       
Dysgeusia  1/6 (16.67%)  0/0  0/0 
Headache  1/6 (16.67%)  0/0  0/0 
Peripheral motor neuropathy  2/6 (33.33%)  0/0  0/0 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  2/6 (33.33%)  0/0  0/0 
Skin and subcutaneous tissue disorders       
Dry skin  1/6 (16.67%)  0/0  0/0 
Rash maculo-papular  1/6 (16.67%)  0/0  0/0 
In preparing to re-open for randomized enrollment in November, 2008 the study committee was asked to amend the study and the decision was made to close AEWS0521 for administrative purpose.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00516295     History of Changes
Other Study ID Numbers: NCI-2009-00369
NCI-2009-00369 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AEWS0521 ( Other Identifier: Children's Oncology Group )
AEWS0521 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2007
First Posted: August 15, 2007
Results First Submitted: December 18, 2013
Results First Posted: September 2, 2014
Last Update Posted: September 2, 2014