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Trial record 2 of 12 for:    "Wilms Tumor 1" | "Hormones"

Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01305200
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : May 9, 2017
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Supportive Care
Conditions Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Chronic Myelogenous Leukemia
Childhood Myelodysplastic Syndromes
Chronic Eosinophilic Leukemia
Chronic Myelomonocytic Leukemia
Chronic Neutrophilic Leukemia
de Novo Myelodysplastic Syndromes
Disseminated Neuroblastoma
Juvenile Myelomonocytic Leukemia
Mucositis
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Previously Treated Childhood Rhabdomyosarcoma
Previously Treated Myelodysplastic Syndromes
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Small Noncleaved Cell Lymphoma
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Recurrent/Refractory Childhood Hodgkin Lymphoma
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Unspecified Childhood Solid Tumor, Protocol Specific
Interventions Drug: supersaturated calcium phosphate rinse
Other: placebo
Other: questionnaire administration
Procedure: quality-of-life assessment
Enrollment 226
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse) Arm III (Enrolled But Not Randomized)
Hide Arm/Group Description

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Site not randomized
Period Title: Overall Study
Started 111 112 3
Completed 82 81 0
Not Completed 29 31 3
Reason Not Completed
Physician Decision             4             6             1
Withdrawal by Subject             24             21             1
Ineligible             1             2             1
Death             0             2             0
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse) Arm III (Enrolled Not Randomized) Total
Hide Arm/Group Description

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Site not able to randomize. Total of all reporting groups
Overall Number of Baseline Participants 111 112 3 226
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 112 participants 3 participants 226 participants
12.75  (5.05) 13.02  (4.54) 12.00  (1.73) 12.88  (4.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 112 participants 3 participants 226 participants
Female
54
  48.6%
48
  42.9%
2
  66.7%
104
  46.0%
Male
57
  51.4%
64
  57.1%
1
  33.3%
122
  54.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 112 participants 3 participants 226 participants
Hispanic or Latino
25
  22.5%
29
  25.9%
1
  33.3%
55
  24.3%
Not Hispanic or Latino
82
  73.9%
79
  70.5%
2
  66.7%
163
  72.1%
Unknown or Not Reported
4
   3.6%
4
   3.6%
0
   0.0%
8
   3.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 112 participants 3 participants 226 participants
American Indian or Alaska Native
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.4%
Asian
2
   1.8%
4
   3.6%
0
   0.0%
6
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  10.8%
11
   9.8%
0
   0.0%
23
  10.2%
White
87
  78.4%
82
  73.2%
3
 100.0%
172
  76.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
10
   9.0%
14
  12.5%
0
   0.0%
24
  10.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 112 participants 3 participants 226 participants
Canada
5
   4.5%
4
   3.6%
0
   0.0%
9
   4.0%
United States
105
  94.6%
102
  91.1%
3
 100.0%
210
  92.9%
Australia
1
   0.9%
5
   4.5%
0
   0.0%
6
   2.7%
Puerto Rico
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.4%
1.Primary Outcome
Title Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
Hide Description Mean days of severe (WHO Grade 3 or 4) Mucositis.
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients defined as patients with >= 11 daily WHO assessments.
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 91 91
Mean (Standard Deviation)
Unit of Measure: Number of days
4.5  (4.8) 4.5  (5)
2.Secondary Outcome
Title Incidence of Severe Oral Mucositis
Hide Description Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients defined as patients with >= 11 daily WHO assessments.
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 91 91
Measure Type: Number
Unit of Measure: percent of patients
68 63
3.Secondary Outcome
Title Oral Mucositis Daily Questionnaire (OMDQ)
Hide Description Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients defined as patients with ≥11 daily WHO assessments.
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 91 91
Mean (Standard Deviation)
Unit of Measure: units on a scale * day
Sleeping 9.3  (10.9) 7.3  (9)
Mouth and Throat Pain 22.3  (14.8) 21.4  (14.7)
Swallowing 21.4  (15.7) 19.9  (15.9)
Drinking 21.7  (16.3) 20.6  (17.3)
Eating 27.9  (19.4) 26.6  (20.7)
Talking 12.2  (11.5) 12  (13.2)
4.Secondary Outcome
Title Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Hide Description Opioid Administration = yes
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II)
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Measure Type: Number
Unit of Measure: percentage of participants
88.7 91.3
5.Secondary Outcome
Title Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Hide Description Mean days of parenteral opioid analgesic use.
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Mean (Standard Deviation)
Unit of Measure: Days
14.2  (9.5) 12.5  (8.7)
6.Secondary Outcome
Title Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
Hide Description Morphine equivalent dose in mg/kg/day
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Median (Full Range)
Unit of Measure: mg/kg/day of opioid analgesics
0.4
(0 to 33.2)
0.3
(0 to 13.4)
7.Secondary Outcome
Title Incidence of Total Parenteral Nutrition (TPN) Administration.
Hide Description Total Parenteral Nutrition = yes
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Measure Type: Number
Unit of Measure: percentage of participants
78.3 72.1
8.Secondary Outcome
Title Duration of Total Parenteral Nutrition (TPN) Administration.
Hide Description Mean days of total parenteral nutrition (TPN) administration.
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Mean (Standard Deviation)
Unit of Measure: Number of days
13.6  (9.9) 11.4  (8.9)
9.Secondary Outcome
Title Incidence of Febrile Neutropenia
Hide Description Fever and Neutropenia = yes
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Measure Type: Number
Unit of Measure: percentage of participants
65.1 67.3
10.Secondary Outcome
Title Incidence of Invasive Bacterial Infections
Hide Description Invasive Bacterial Infection = yes
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 106 104
Measure Type: Number
Unit of Measure: percentage of participants
6.6 7.7
11.Secondary Outcome
Title Severity of Mucositis
Hide Description Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain.
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients defined as patients with ≥11 daily WHO assessments.
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 91 91
Mean (Standard Deviation)
Unit of Measure: units on a scale * day
45.5  (36) 44  (35.6)
12.Other Pre-specified Outcome
Title Ancillary Validation Study of ChIMES
Hide Description [Not Specified]
Time Frame Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is not performed at this time due to no available funding and no human resource allocated to this study.
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description:

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Total of 210 patients evaluable for toxicity (106 Arm I & 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
 
Arm/Group Title Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Hide Arm/Group Description

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

placebo: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.

supersaturated calcium phosphate rinse: Mouth rinse

questionnaire administration: Ancillary studies

quality-of-life assessment: Ancillary studies

All-Cause Mortality
Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   3/104 (2.88%) 
Infections and infestations     
Infections and infestations - Other, specify  0/106 (0.00%)  1/104 (0.96%) 
Sepsis  0/106 (0.00%)  1/104 (0.96%) 
Nervous system disorders     
Intracranial hemorrhage  0/106 (0.00%)  1/104 (0.96%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Placebo) Arm II (Supersaturated Calcium Phosphate Rinse)
Affected / at Risk (%) Affected / at Risk (%)
Total   29/106 (27.36%)   22/104 (21.15%) 
Gastrointestinal disorders     
Diarrhea  0/106 (0.00%)  1/104 (0.96%) 
Oral pain  16/106 (15.09%)  13/104 (12.50%) 
General disorders     
Pain  1/106 (0.94%)  0/104 (0.00%) 
Immune system disorders     
Allergic reaction  0/106 (0.00%)  1/104 (0.96%) 
Anaphylaxis  0/106 (0.00%)  1/104 (0.96%) 
Infections and infestations     
Infections and infestations - Other, specify  12/106 (11.32%)  8/104 (7.69%) 
Urinary tract infection  1/106 (0.94%)  0/104 (0.00%) 
Investigations     
Neutrophil count decreased  0/106 (0.00%)  1/104 (0.96%) 
Metabolism and nutrition disorders     
Hypocalcemia  1/106 (0.94%)  0/104 (0.00%) 
Hypokalemia  1/106 (0.94%)  0/104 (0.00%) 
Nervous system disorders     
Dysgeusia  2/106 (1.89%)  2/104 (1.92%) 
Seizure  1/106 (0.94%)  0/104 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash acneiform  1/106 (0.94%)  0/104 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreporingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01305200     History of Changes
Other Study ID Numbers: ACCL1031
NCI-2011-02635 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000695718 ( Other Identifier: Clinical Trials.gov )
ACCL1031 ( Other Identifier: Children's Oncology Group )
COG-ACCL1031 ( Other Identifier: DCP )
ACCL1031 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
First Submitted: February 25, 2011
First Posted: February 28, 2011
Results First Submitted: November 30, 2016
Results First Posted: May 9, 2017
Last Update Posted: September 17, 2019