Trial Outcomes & Findings for Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors (NCT NCT00061893)

Last Updated: 2019-02-15

Results Overview

An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

The first two cycles (6 weeks) of protocol chemotherapy

Results posted on

2019-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Combination Chemotherapy Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
Overall Study STARTED	38
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Chemotherapy n=38 Participants Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
Age, Continuous	12.97 years STANDARD_DEVIATION 5.81 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants

PRIMARY outcome

Timeframe: The first two cycles (6 weeks) of protocol chemotherapy

Population: By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of severe toxicity. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.

Outcome measures

Outcome measures
Measure	Combination Chemotherapy n=35 Participants Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
Occurrence of Severe Toxicity Grade 3 or Higher Sensory Neuropathy	1 participants
Occurrence of Severe Toxicity Grade 3 or Higher Infection	1 participants

SECONDARY outcome

Timeframe: 24 months after start of protocol therapy

Population: By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of Event Free Survival. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.

Outcome measures

Outcome measures
Measure	Combination Chemotherapy n=35 Participants Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
Event Free Survival	35 percentage of participants Interval 19.0 to 51.0

Adverse Events

Combination Chemotherapy

Serious events: 33 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Chemotherapy n=35 participants at risk Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
Gastrointestinal disorders Abdominal pain	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Activated partial thromboplastin time prolonged	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Alanine aminotransferase increased	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Blood and lymphatic system disorders Anemia	34.3% 12/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Anorexia	17.1% 6/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Aspartate aminotransferase increased	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Bladder infection	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Bladder spasm	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Blood bilirubin increased	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Bronchial infection	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Catheter related infection	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Colitis	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Constipation	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Cystitis noninfective	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Dehydration	11.4% 4/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Diarrhea	11.4% 4/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Dysphagia	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Electrocardiogram QT corrected interval prolonged	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Esophagitis	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
General disorders Fatigue	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Blood and lymphatic system disorders Febrile neutropenia	42.9% 15/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
General disorders Fever	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Fibrinogen decreased	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Forced expiratory volume decreased	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Gastritis	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations GGT increased	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Hematuria	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hyperglycemia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hyperkalemia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypermagnesemia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypernatremia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypoalbuminemia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypocalcemia	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypokalemia	40.0% 14/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypomagnesemia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hyponatremia	17.1% 6/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypophosphatemia	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Vascular disorders Hypotension	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Respiratory, thoracic and mediastinal disorders Hypoxia	17.1% 6/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Ileus	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Infections and infestations - Other, specify	51.4% 18/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Intra-abdominal hemorrhage	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Lung infection	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Lymphocyte count decreased	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Mucositis oral	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Cardiac disorders Myocardial infarction	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Nausea	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Neutrophil count decreased	54.3% 19/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Skin and subcutaneous tissue disorders Pain of skin	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Cardiac disorders Pericardial effusion	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Reproductive system and breast disorders Perineal pain	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Nervous system disorders Peripheral motor neuropathy	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Nervous system disorders Peripheral sensory neuropathy	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Platelet count decreased	45.7% 16/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Sepsis	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Upper respiratory infection	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Urinary retention	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Urinary tract infection	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Injury, poisoning and procedural complications Vascular access complication	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Nervous system disorders Vasovagal reaction	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Vomiting	11.4% 4/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Weight loss	11.4% 4/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations White blood cell decreased	45.7% 16/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Wound infection	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.

Other adverse events

Other adverse events
Measure	Combination Chemotherapy n=35 participants at risk Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
Metabolism and nutrition disorders Acidosis	25.7% 9/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Activated partial thromboplastin time prolonged	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Alanine aminotransferase increased	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Blood and lymphatic system disorders Anemia	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Aspartate aminotransferase increased	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Bladder spasm	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations Blood bilirubin increased	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Injury, poisoning and procedural complications Burn	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Catheter related infection	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Constipation	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Psychiatric disorders Depression	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Gastritis	22.9% 8/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Hematuria	34.3% 12/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hyperglycemia	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypermagnesemia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Vascular disorders Hypertension	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypoalbuminemia	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypocalcemia	8.6% 3/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypokalemia	25.7% 9/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Metabolism and nutrition disorders Hypophosphatemia	48.6% 17/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Infections and infestations - Other, specify	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Investigations INR increased	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Intra-abdominal hemorrhage	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Mucositis oral	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Nervous system disorders Peripheral motor neuropathy	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Nervous system disorders Peripheral sensory neuropathy	11.4% 4/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Proctitis	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Proteinuria	42.9% 15/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Psychiatric disorders Psychosis	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Skin and subcutaneous tissue disorders Rash maculo-papular	28.6% 10/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Vascular disorders Thromboembolic event	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Urinary frequency	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Infections and infestations Urinary tract infection	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Renal and urinary disorders Urinary tract pain	2.9% 1/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Gastrointestinal disorders Vomiting	5.7% 2/35 By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place