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Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma

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ClinicalTrials.gov Identifier: NCT01222715
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
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 Adult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Pleomorphic Rhabdomyosarcoma
Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Childhood Rhabdomyosarcoma
Interventions Biological: Bevacizumab
Drug: Cyclophosphamide
Other: Laboratory Biomarker Analysis
Drug: Temsirolimus
Drug: Vinorelbine Tartrate
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks. The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
Period Title: Overall Study
Started 44 43
Completed 8 16
Not Completed 36 27
Reason Not Completed
Adverse Event             0             4
Death             0             1
Lack of Efficacy             22             14
Physician Decision             12             2
Refusal of further protocol therapy             0             4
Pt cannot receive treatment for >9 wks             1             1
Ineligible             0             1
Surgery or radiation therapy in 1st 6 wk             1             0
Arm/Group Title Regimen A Regimen B Total
Hide Arm/Group Description The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks. The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously. Total of all reporting groups
Overall Number of Baseline Participants 44 43 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 44 participants 43 participants 87 participants
116.35  (72.82) 140.65  (75.93) 128.36  (74.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 43 participants 87 participants
Female
22
  50.0%
20
  46.5%
42
  48.3%
Male
22
  50.0%
23
  53.5%
45
  51.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 43 participants 87 participants
Hispanic or Latino
9
  20.5%
10
  23.3%
19
  21.8%
Not Hispanic or Latino
35
  79.5%
31
  72.1%
66
  75.9%
Unknown or Not Reported
0
   0.0%
2
   4.7%
2
   2.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 43 participants 87 participants
American Indian or Alaska Native
1
   2.3%
1
   2.3%
2
   2.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   2.3%
1
   2.3%
2
   2.3%
Black or African American
7
  15.9%
7
  16.3%
14
  16.1%
White
30
  68.2%
27
  62.8%
57
  65.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  11.4%
7
  16.3%
12
  13.8%
1.Primary Outcome
Title Event Free Survival Probability
Hide Description Probability of no relapse, secondary malignancy, or death after 1 year in the study.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible participants were analyzed.
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description:
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
Overall Number of Participants Analyzed 44 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.23
(0.10 to 0.35)
0.43
(0.28 to 0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen A, Regimen B
Comments The event free survival distributions of patients in Regimen A and Regimen B were compared using the log-rank test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0124
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title Rate of Dose-Limiting Toxicities
Hide Description The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays > 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis > 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP).
Time Frame From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible participants were analyzed.
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description:
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
Overall Number of Participants Analyzed 44 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2
(0 to 7)
21
(9 to 34)
3.Secondary Outcome
Title Response Rate (CR + PR)
Hide Description Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Time Frame From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible participants with overall response evaluated were analyzed.
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description:
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
Overall Number of Participants Analyzed 40 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.3250
(0.1799 to 0.4701)
0.4737
(0.3149 to 0.6324)
4.Other Pre-specified Outcome
Title Biomarker Levels
Hide Description Biomarker data will be summarized for each response category, at each time point using either means and standard deviations or medians and ranges.
Time Frame Up to 36 weeks
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Changes in Angiogenesis-associated Plasma Markers Between Patients by Treatment
Hide Description First, the distributions of these markers will be compared at ‘end of 2 cycles’ between treatments using a 2-independent sample non-parametric test. The mean will also be modeled for each of these markers (or a transformation of the marker to near normality) as a function of time and treatment using GEEs which are designed to take into account the internal correlation of repeated measurements taken on the same subject. Associations between progression-free survival and changes in each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.
Time Frame Baseline up to day 42
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Clinical Predictors, Including Histologic and Molecular Subtype, Age, Stage, and Site
Hide Description These known risk factors will be compared to genomic features like gene and ribonucleic acid (RNA) expression values, as well as combinations of the two and splice variants of known genes, in order to identify those features most related to treatment resistance and poor outcome (overall survival and failure-free survival) using a Cox proportional hazards model of gene expression with cross validation.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Clinical Response
Hide Description The data reported in 2 groups will be summarized using numbers and percentages of patients in each stratum and at each time point (baseline, after course 2, at the time of best response and end of therapy or progressive disease, whichever comes first). A binomial generalized estimating equation (GEE) model will be fitted to the data. The variables in the model will be time, treatment group and a biomarker. The beta coefficient of the biomarker will quantify the strength of the association between clinical response and the biomarker, beyond the association of the outcome to the other variables.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Levels of Biomarkers Related to the Effect of Temsirolimus on the Unfolded Protein Response
Hide Description [Not Specified]
Time Frame Up to 36 weeks
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Progression-free Survival
Hide Description Progression-free survival data will be explored using Kaplan Meier analysis. Associations between this outcome and each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description Vinorelbine/cyclophosphamide (VC) + bevacizumab Vinorelbine/cyclophosphamide (VC) + temsirolimus
All-Cause Mortality
Regimen A Regimen B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Regimen A Regimen B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/44 (79.55%)      32/42 (76.19%)    
Blood and lymphatic system disorders     
Anemia  1/44 (2.27%)  1 1/42 (2.38%)  1
Febrile neutropenia  4/44 (9.09%)  7 9/42 (21.43%)  15
Gastrointestinal disorders     
Abdominal pain  1/44 (2.27%)  1 0/42 (0.00%)  0
Dental caries  1/44 (2.27%)  1 0/42 (0.00%)  0
Diarrhea  1/44 (2.27%)  1 1/42 (2.38%)  2
Esophagitis  0/44 (0.00%)  0 1/42 (2.38%)  2
Mucositis oral  1/44 (2.27%)  1 6/42 (14.29%)  6
Nausea  1/44 (2.27%)  1 1/42 (2.38%)  1
Oral pain  0/44 (0.00%)  0 1/42 (2.38%)  1
Small intestinal obstruction  0/44 (0.00%)  0 1/42 (2.38%)  1
Typhlitis  0/44 (0.00%)  0 1/42 (2.38%)  1
Vomiting  1/44 (2.27%)  1 1/42 (2.38%)  1
General disorders     
Death NOS  27/44 (61.36%)  27 15/42 (35.71%)  15
General disorders and administration site conditions - Other, specify  1/44 (2.27%)  1 0/42 (0.00%)  0
Pain  1/44 (2.27%)  1 0/42 (0.00%)  0
Infections and infestations     
Catheter related infection  0/44 (0.00%)  0 1/42 (2.38%)  1
Esophageal infection  0/44 (0.00%)  0 1/42 (2.38%)  1
Sepsis  3/44 (6.82%)  3 0/42 (0.00%)  0
Wound infection  0/44 (0.00%)  0 1/42 (2.38%)  1
Investigations     
Aspartate aminotransferase increased  0/44 (0.00%)  0 1/42 (2.38%)  1
CPK increased  0/44 (0.00%)  0 1/42 (2.38%)  1
Ejection fraction decreased  1/44 (2.27%)  1 0/42 (0.00%)  0
Lymphocyte count decreased  1/44 (2.27%)  1 0/42 (0.00%)  0
Neutrophil count decreased  0/44 (0.00%)  0 2/42 (4.76%)  2
Platelet count decreased  0/44 (0.00%)  0 1/42 (2.38%)  1
Weight loss  0/44 (0.00%)  0 1/42 (2.38%)  1
Metabolism and nutrition disorders     
Dehydration  1/44 (2.27%)  1 3/42 (7.14%)  4
Hypertriglyceridemia  0/44 (0.00%)  0 4/42 (9.52%)  6
Hypokalemia  0/44 (0.00%)  0 2/42 (4.76%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Leukemia secondary to oncology chemotherapy  0/44 (0.00%)  0 1/42 (2.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  3/44 (6.82%)  3 7/42 (16.67%)  7
Treatment related secondary malignancy  1/44 (2.27%)  2 1/42 (2.38%)  1
Renal and urinary disorders     
Acute kidney injury  0/44 (0.00%)  0 1/42 (2.38%)  1
Urinary tract obstruction  1/44 (2.27%)  1 0/42 (0.00%)  0
Reproductive system and breast disorders     
Reproductive system and breast disorders - Other, specify  1/44 (2.27%)  2 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Atelectasis  0/44 (0.00%)  0 1/42 (2.38%)  1
Epistaxis  2/44 (4.55%)  2 0/42 (0.00%)  0
Hypoxia  0/44 (0.00%)  0 1/42 (2.38%)  1
Pleural effusion  0/44 (0.00%)  0 2/42 (4.76%)  2
Pneumonitis  0/44 (0.00%)  0 1/42 (2.38%)  1
Respiratory failure  1/44 (2.27%)  1 1/42 (2.38%)  1
Stridor  1/44 (2.27%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders - Other, specify  1/44 (2.27%)  4 0/42 (0.00%)  0
Vascular disorders     
Hypotension  0/44 (0.00%)  0 2/42 (4.76%)  2
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regimen A Regimen B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/44 (63.64%)      30/42 (71.43%)    
Blood and lymphatic system disorders     
Anemia  7/44 (15.91%)  8 8/42 (19.05%)  8
Febrile neutropenia  7/44 (15.91%)  12 7/42 (16.67%)  20
Cardiac disorders     
Pericardial effusion  0/44 (0.00%)  0 1/42 (2.38%)  1
Endocrine disorders     
Adrenal insufficiency  1/44 (2.27%)  1 0/42 (0.00%)  0
Hypothyroidism  1/44 (2.27%)  1 0/42 (0.00%)  0
Eye disorders     
Conjunctivitis  2/44 (4.55%)  2 0/42 (0.00%)  0
Eye disorders - Other, specify  1/44 (2.27%)  1 0/42 (0.00%)  0
Eye pain  1/44 (2.27%)  1 0/42 (0.00%)  0
Eyelid function disorder  0/44 (0.00%)  0 1/42 (2.38%)  1
Keratitis  1/44 (2.27%)  1 0/42 (0.00%)  0
Photophobia  1/44 (2.27%)  1 0/42 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  0/44 (0.00%)  0 4/42 (9.52%)  4
Ascites  0/44 (0.00%)  0 1/42 (2.38%)  1
Constipation  1/44 (2.27%)  1 1/42 (2.38%)  1
Dental caries  1/44 (2.27%)  1 0/42 (0.00%)  0
Diarrhea  1/44 (2.27%)  1 1/42 (2.38%)  1
Esophagitis  0/44 (0.00%)  0 1/42 (2.38%)  1
Ileus  1/44 (2.27%)  1 1/42 (2.38%)  2
Mucositis oral  1/44 (2.27%)  1 2/42 (4.76%)  3
Nausea  0/44 (0.00%)  0 1/42 (2.38%)  1
Oral pain  1/44 (2.27%)  1 0/42 (0.00%)  0
Vomiting  1/44 (2.27%)  1 0/42 (0.00%)  0
General disorders     
Edema face  0/44 (0.00%)  0 1/42 (2.38%)  1
Facial pain  1/44 (2.27%)  1 0/42 (0.00%)  0
Fatigue  1/44 (2.27%)  1 1/42 (2.38%)  1
Fever  0/44 (0.00%)  0 1/42 (2.38%)  1
Non-cardiac chest pain  0/44 (0.00%)  0 1/42 (2.38%)  1
Pain  6/44 (13.64%)  6 2/42 (4.76%)  2
Infections and infestations     
Infections and infestations - Other, specify  1/44 (2.27%)  2 0/42 (0.00%)  0
Mucosal infection  0/44 (0.00%)  0 1/42 (2.38%)  1
Pelvic infection  0/44 (0.00%)  0 1/42 (2.38%)  1
Skin infection  0/44 (0.00%)  0 1/42 (2.38%)  1
Upper respiratory infection  1/44 (2.27%)  1 0/42 (0.00%)  0
Urinary tract infection  0/44 (0.00%)  0 1/42 (2.38%)  1
Wound infection  1/44 (2.27%)  1 0/42 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  2/44 (4.55%)  2 0/42 (0.00%)  0
Alanine aminotransferase increased  1/44 (2.27%)  1 5/42 (11.90%)  8
Alkaline phosphatase increased  0/44 (0.00%)  0 1/42 (2.38%)  1
Aspartate aminotransferase increased  0/44 (0.00%)  0 3/42 (7.14%)  4
Blood bilirubin increased  1/44 (2.27%)  1 0/42 (0.00%)  0
Cholesterol high  1/44 (2.27%)  1 1/42 (2.38%)  1
Creatinine increased  0/44 (0.00%)  0 1/42 (2.38%)  1
Ejection fraction decreased  0/44 (0.00%)  0 1/42 (2.38%)  1
INR increased  1/44 (2.27%)  1 0/42 (0.00%)  0
Investigations - Other, specify  1/44 (2.27%)  1 0/42 (0.00%)  0
Lymphocyte count decreased  6/44 (13.64%)  11 6/42 (14.29%)  9
Neutrophil count decreased  3/44 (6.82%)  12 4/42 (9.52%)  6
Platelet count decreased  6/44 (13.64%)  9 4/42 (9.52%)  8
White blood cell decreased  5/44 (11.36%)  10 5/42 (11.90%)  6
Metabolism and nutrition disorders     
Anorexia  2/44 (4.55%)  3 2/42 (4.76%)  2
Hyperglycemia  5/44 (11.36%)  5 4/42 (9.52%)  6
Hyperkalemia  1/44 (2.27%)  1 0/42 (0.00%)  0
Hypertriglyceridemia  1/44 (2.27%)  1 5/42 (11.90%)  5
Hypoalbuminemia  7/44 (15.91%)  7 1/42 (2.38%)  1
Hypocalcemia  1/44 (2.27%)  1 1/42 (2.38%)  1
Hypokalemia  1/44 (2.27%)  2 5/42 (11.90%)  10
Hyponatremia  3/44 (6.82%)  3 1/42 (2.38%)  1
Hypophosphatemia  1/44 (2.27%)  1 2/42 (4.76%)  2
Musculoskeletal and connective tissue disorders     
Back pain  5/44 (11.36%)  5 3/42 (7.14%)  3
Generalized muscle weakness  1/44 (2.27%)  1 0/42 (0.00%)  0
Muscle weakness lower limb  0/44 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorder - Other, specify  0/44 (0.00%)  0 1/42 (2.38%)  2
Pain in extremity  0/44 (0.00%)  0 1/42 (2.38%)  1
Trismus  0/44 (0.00%)  0 1/42 (2.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1/44 (2.27%)  1 0/42 (0.00%)  0
Tumor pain  1/44 (2.27%)  1 3/42 (7.14%)  3
Nervous system disorders     
Ataxia  0/44 (0.00%)  0 1/42 (2.38%)  1
Facial muscle weakness  1/44 (2.27%)  1 0/42 (0.00%)  0
Facial nerve disorder  1/44 (2.27%)  1 0/42 (0.00%)  0
Headache  1/44 (2.27%)  1 0/42 (0.00%)  0
Neuralgia  0/44 (0.00%)  0 1/42 (2.38%)  1
Oculomotor nerve disorder  0/44 (0.00%)  0 1/42 (2.38%)  1
Peripheral motor neuropathy  1/44 (2.27%)  1 2/42 (4.76%)  2
Peripheral sensory neuropathy  0/44 (0.00%)  0 3/42 (7.14%)  3
Psychiatric disorders     
Anxiety  2/44 (4.55%)  2 3/42 (7.14%)  3
Depression  2/44 (4.55%)  2 2/42 (4.76%)  2
Renal and urinary disorders     
Hematuria  0/44 (0.00%)  0 1/42 (2.38%)  1
Proteinuria  1/44 (2.27%)  1 0/42 (0.00%)  0
Renal calculi  0/44 (0.00%)  0 1/42 (2.38%)  1
Urinary retention  0/44 (0.00%)  0 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1/44 (2.27%)  1 0/42 (0.00%)  0
Epistaxis  1/44 (2.27%)  2 0/42 (0.00%)  0
Hypoxia  0/44 (0.00%)  0 2/42 (4.76%)  2
Nasal congestion  1/44 (2.27%)  1 0/42 (0.00%)  0
Pleural effusion  0/44 (0.00%)  0 3/42 (7.14%)  3
Pleuritic pain  0/44 (0.00%)  0 1/42 (2.38%)  1
Stridor  1/44 (2.27%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  0/44 (0.00%)  0 1/42 (2.38%)  1
Dry skin  0/44 (0.00%)  0 2/42 (4.76%)  2
Rash acneiform  1/44 (2.27%)  1 0/42 (0.00%)  0
Rash maculo-papular  1/44 (2.27%)  1 0/42 (0.00%)  0
Vascular disorders     
Hypertension  1/44 (2.27%)  1 1/42 (2.38%)  1
Hypotension  0/44 (0.00%)  0 1/42 (2.38%)  1
Lymphedema  0/44 (0.00%)  0 1/42 (2.38%)  1
1
Term from vocabulary, CTCv4
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: NCT01222715     History of Changes
Other Study ID Numbers: NCI-2011-02607
NCI-2011-02607 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST0921
CDR0000687113
ARST0921
ARST0921 ( Other Identifier: Childrens Oncology Group )
ARST0921 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2010
First Posted: October 18, 2010
Results First Submitted: January 9, 2017
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017