Trial · NCT00033293

Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma

NCT00033293, Phase 3, Completed, Children's Oncology Group; results first posted 2016-10-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma. Trials, record NCT00033293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00033293

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
NCT number: NCT00033293
Status: Completed
Phases: Phase 3
Enrollment: 53 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
Interventions: Clinical Observation, Cyclophosphamide, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Prednisone, Therapeutic Immune Globulin
First posted: 2003-01-27
Last updated: 2023-04-18
Results first posted: 2016-10-03

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Responders	Changes from baseline to 2 months, 6 months, and 1 year	A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.
Secondary	Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)	Changes from baseline to the better of 6 months or 1 year	The "best" score at the two time points will be used in this analysis. For a given patient, this "best" score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated.
Secondary	Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing	Changes from baseline to the better of 6 months or 1 year	The Bayley Scales of infant development mental scale "best" score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline.
Secondary	Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology	At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis	Descriptive analyses on biologic variables will be performed
Secondary	Long-term Prognosis for Neurologic Recovery by Neurological Examination	At diagnosis and yearly for 10 years after diagnosis	A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.
Secondary	Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death	Up to 3 years	EFS rate for neuroblastoma event from time of study enrollment.
Secondary	Tumor Outcome in Terms of Overall Survival (OS) Rate	Up to 3 years	OS rate from time of study enrollment.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Responders	Changes from baseline to 2 months, 6 months, and 1 year	Eligible patients	participants	NUMBER
SECONDARY	Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)	Changes from baseline to the better of 6 months or 1 year	All eligible patients who had VABS measures at diagnosis and at least one of 6 months or 1 year.	Change in VABS score	MEAN
SECONDARY	Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing	Changes from baseline to the better of 6 months or 1 year	All eligible patients who had Bayley's measures at diagnosis and at least one of 6 months or 1 year.	Change in Bayley's score	MEAN
SECONDARY	Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology	At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis	The necessary data will never be collected, therefore results can't be provided.
SECONDARY	Long-term Prognosis for Neurologic Recovery by Neurological Examination	At diagnosis and yearly for 10 years after diagnosis	The necessary data will never be collected, therefore results can't be provided.
SECONDARY	Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death	Up to 3 years	All eligible randomized patients.	3 year EFS	NUMBER
SECONDARY	Tumor Outcome in Terms of Overall Survival (OS) Rate	Up to 3 years	All eligible randomized patients.	3 year OS	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Responders	Arm I (Chemotherapy, Immunoglobulin Therapy)	21		participants
Number of Responders	Arm II (Chemotherapy, Observation)	11		participants
Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)	Arm I (Chemotherapy, Immunoglobulin Therapy)	84.53	Standard Deviation 115.91	Change in VABS score
Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)	Arm II (Chemotherapy, Observation)	144.73	Standard Deviation 110.69	Change in VABS score
Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing	Arm I (Chemotherapy, Immunoglobulin Therapy)	117.5	Standard Deviation 35.35	Change in Bayley's score
Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing	Arm II (Chemotherapy, Observation)	100.75	Standard Deviation 25.76	Change in Bayley's score
Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death	Arm I (Chemotherapy, Immunoglobulin Therapy)	92.3	95% Confidence Interval 81.8 to 100	3 year EFS
Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death	Arm II (Chemotherapy, Observation)	96.0	95% Confidence Interval 87.8 to 100	3 year EFS
Tumor Outcome in Terms of Overall Survival (OS) Rate	Arm I (Chemotherapy, Immunoglobulin Therapy)	100	95% Confidence Interval 100 to 100	3 year OS
Tumor Outcome in Terms of Overall Survival (OS) Rate	Arm II (Chemotherapy, Observation)	96.0	95% Confidence Interval 87.8 to 100	3 year OS

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Chemotherapy, Immunoglobulin Therapy)	26
Overall Study	STARTED	Arm II (Chemotherapy, Observation)	27
Overall Study	COMPLETED	Arm I (Chemotherapy, Immunoglobulin Therapy)	16
Overall Study	COMPLETED	Arm II (Chemotherapy, Observation)	9
Overall Study	NOT COMPLETED	Arm I (Chemotherapy, Immunoglobulin Therapy)	10
Overall Study	NOT COMPLETED	Arm II (Chemotherapy, Observation)	18

Source ClinicalTrials.gov

Adverse events104

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	13200-Anemia	Blood and lymphatic system disorders	Arm I (Chemotherapy, Immunoglobulin Therapy)	1	26	3
other	13200-Anemia	Blood and lymphatic system disorders	Arm II (Chemotherapy, Observation)	4	27	6
other	33300-Febrile neutropenia	Blood and lymphatic system disorders	Arm I (Chemotherapy, Immunoglobulin Therapy)	1	26	2
other	33300-Febrile neutropenia	Blood and lymphatic system disorders	Arm II (Chemotherapy, Observation)	1	27	3
other	74200-Sinus bradycardia	Cardiac disorders	Arm I (Chemotherapy, Immunoglobulin Therapy)	0	26	0
other	74200-Sinus bradycardia	Cardiac disorders	Arm II (Chemotherapy, Observation)	1	27	1
other	11200-Adrenal insufficiency	Endocrine disorders	Arm I (Chemotherapy, Immunoglobulin Therapy)	0	26	0
other	11200-Adrenal insufficiency	Endocrine disorders	Arm II (Chemotherapy, Observation)	1	27	1
other	24200-Cushingoid	Endocrine disorders	Arm I (Chemotherapy, Immunoglobulin Therapy)	0	26	0
other	24200-Cushingoid	Endocrine disorders	Arm II (Chemotherapy, Observation)	2	27	3

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Chemotherapy, Immunoglobulin Therapy)
Total, all-cause mortality	Arm II (Chemotherapy, Observation)
Total, other adverse events	Arm I (Chemotherapy, Immunoglobulin Therapy)	13	26
Total, other adverse events	Arm II (Chemotherapy, Observation)	18	27
Total, serious adverse events	Arm I (Chemotherapy, Immunoglobulin Therapy)	1	26
Total, serious adverse events	Arm II (Chemotherapy, Observation)	1	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29376112	DERIVED

Source PubMed

Grants3

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER
U10CA013539	CHILDRENS CANCER GROUP CHAIRMANS AWARD	REAMAN, GREGORY H	NATIONAL CHILDHOOD CANCER FOUNDATION	NATIONAL CANCER INSTITUTE	1985 to 2002	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (Chemotherapy, Immunoglobulin Therapy) vs Arm II (Chemotherapy, Observation): Number of Responders	Trial comparisons
Arm I (Chemotherapy, Immunoglobulin Therapy) vs Arm II (Chemotherapy, Observation): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00033293

GET https://conductscience.org/api/trials/v1/NCT00033293/events?page=2

API reference For AI assistants