Trial · NCT00202930
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
NCT00202930, Phase 2, Terminated, Jean M. Tersak, M.D.; results first posted 2021-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma. Trials, record NCT00202930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00202930
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
- NCT number
- NCT00202930
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Jean M. Tersak, M.D.
- Conditions
- Neuroblastoma, Opsoclonus-myoclonus
- Interventions
- anti-CD20 (Rituximab)
- First posted
- 2005-09-20
- Last updated
- 2021-01-22
- Results first posted
- 2021-01-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Using 4 Weekly Rituximab Infusions | 4 weeks | To evaluate the feasibility of using 4 weekly Rituximab infusions in the treatment of children with neuroblastoma associated opsoclonus-myoclonus syndrome (OMS). The first infusion involved a slow up titration from an initial rate of 0.5 mg/kg/hour to a maximum of 400 mg/hour. If well tolerated, the subsequent infusions were administered at a starting rate of 1 mg/kg/hour to a maximum of 100 mg/hour for the first hour. In the absence of adverse reaction doses were escalated by 1 mg/kg/hour (maximum 100 mg increase per hour) every 30 minutes to a maximum rate of 400 mg/hour. If hypersensitivity or infusion related events occurred, the infusion was temporarily interrupted and resumed at 50% of the previous rate if reaction resolves. The number of participants for whom the study dosing was feasible is reported. |
| Primary | Toxicity of Rituximab | Individuals were followed for adverse events until day 270 | The trial was to be terminated early for any grade 3 or 4 toxicity that did not resolve in 2 of the first 5 patients treated, or for any infusion related death. The number of participants who experienced these events \[grade 3 or 4 toxicity that did not resolve in 2 of the first 5 patients treated, or for any infusion related death\] is reported. |
| Secondary | OMS Evaluation Scale of Motor-Performance | Baseline, following the four infusions, at months 3, 6, 12, 18 and 24 following the first infusion. | OMS Evaluation Scale of Motor-Performance This scoring system utilizes a scale of 0 to 3, with 0 being unaffected by OMS, and 3 representing those with severe impairment. OMS testing will be scored by two independent scorers who have special expertise in the evaluation and management of children with neurologic disorders. The mean of these scores will be obtained, and a standard error of the mean reported. |
| Secondary | Human-anti-chimeric Antibody (HACA) Development | Baseline; 3, 6, 9 months post treatment | Blood samples to be evaluated for the occurrence of antibody formation and potential effect on pharmacokinetic profiles. |
| Secondary | Peripheral B Cell Depletion | 2 years | B cell depletion was measured through analysis of serum IgG levels. The number of participants who experienced B cell depletion is reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility of Using 4 Weekly Rituximab Infusions | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Toxicity of Rituximab | Individuals were followed for adverse events until day 270 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | OMS Evaluation Scale of Motor-Performance | Baseline, following the four infusions, at months 3, 6, 12, 18 and 24 following the first infusion. | score on a scale | MEAN | |
| SECONDARY | Human-anti-chimeric Antibody (HACA) Development | Baseline; 3, 6, 9 months post treatment | These studies were unable to be performed due to withdraw of funding from the study sponsor. 0 of 4 patients participated. | ||
| SECONDARY | Peripheral B Cell Depletion | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility of Using 4 Weekly Rituximab Infusions | Rituximab | 4 | Participants | ||
| Toxicity of Rituximab | Rituximab | 0 | Participants | ||
| OMS Evaluation Scale of Motor-Performance | Rituximab | NA | Full Range NA to NA | score on a scale | |
| Peripheral B Cell Depletion | Rituximab | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 4 | |
| Overall Study | COMPLETED | Rituximab | 4 | |
| Overall Study | NOT COMPLETED | Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events1
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 |
|---|---|---|---|---|---|---|
| serious | Febrile illness with upper respiratory symptoms and dehydration | General disorders | Rituximab | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab | ||
| Total, other adverse events | Rituximab | 0 | 4 |
| Total, serious adverse events | Rituximab | 1 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT00202930
GET https://conductscience.org/api/trials/v1/NCT00202930/registered